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This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Participants will receive atezolizumab SC followed by atezolizumab IV. |
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| Treatment B | Experimental | Participants will receive atezolizumab IV followed by atezolizumab SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered on Day 1 of each 21-day cycle. Participants will receive atezolizumab according to their assigned route of administration (i.e., SC or IV) for the first three treatment cycles. At Cycle 4, participants will cross-over and receive atezolizumab administered according to the alternative route of administration for Cycles 4-6. This period of 3+3 cycles in both treatment arms constitutes the study Treatment Cross-over Period. After Cycle 6, participants will select how they would like atezolizumab to be administered (SC or IV) for the Treatment Continuation Period. The Treatment Continuation Period will continue until Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit, as determined by the investigator according to local standard of care, for patients with advanced NSCLC. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ) | Participants preference was assessed based on the Question 1 of PPQ. Question 1 (All things considered, which route of administration did you prefer?) asks participants to report their preference for the route of administration (IV, SC, or no preference). A point estimate with associated 95% CI for the percentage of participants who preferred atezolizumab SC was calculated. Participants experiencing any of the following events: treatment withdrawal prior to eligibility for PPQ, or death without answering Question 1 of PPQ, or treatment not started; were excluded from the analysis set. Participants who answered Question 1 of the PPQ without having at least 2 consecutive administrations of treatment with each administration modality (SC and IV) were excluded from the analysis. Percentages have been rounded off. As planned, participant preference was summarized and presented by overall (all participants) and by randomized treatment sequence using FAS. | Cycle 6 Day 1 (cycle length=21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV) | TASQ is a 12-item, participant-reported questionnaire measuring the impact of each mode of treatment administration (TASQ-IV for IV treatment and TASQ-SC for SC treatment) on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. TASQ-IV/-SC was administered at treatment Cycles 3 and 6 according to the order of treatment received per arm during the Crossover Period. Participants satisfaction was assessed based on the Question 1 of TASQ-IV/SC which asks participants about their satisfaction with respect to route of administration (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, participant did not answer the question). Question 1 - TASQ- IV (How satisfied or dissatisfied were you with the IV infusion?) and TASQ- SC (How satisfied or dissatisfied were you with the SC injection?) |
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Inclusion Criteria for All Participants:
Inclusion Criteria for Participants with Early-stage NSCLC:
Inclusion Criteria for Participants with Stage IV NSCLC:
Exclusion Criteria for All Participants:
Exclusion Criteria for Participants with Stage IV NSCLC:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey Hematology Oncology Associates LLC | Brick | New Jersey | 08724-3009 | United States | ||
| Tri County Hematologyoncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42214243 | Derived | Burotto M, Zvirbule Z, Alvarez R, Chewaskulyong B, Felip E, Majem M, Korbenfeld E, Kolb-Sielecki J, Isla D, Barata T, Bustillos A, Herraez-Baranda LA, Tosti N, Young F, Zanghi J, Cappuzzo F. Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies. Lung Cancer. 2026 Jul;217:109452. doi: 10.1016/j.lungcan.2026.109452. Epub 2026 May 12. | |
| 41296193 |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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A total of 179 participants with non-small cell lung cancer (NSCLC) were randomized in 1:1 ratio to Arm A (atezolizumab IV followed by atezolizumab SC) or Arm B (atezolizumab SC followed by atezolizumab IV). The study consists of two periods: Treatment Crossover Period, and Treatment Continuation Period.
Participants took part in the study across 37 investigative sites in 12 countries (Spain, Brazil, Finland, Italy, United States, Argentina, Canada, Republic of Korea, Costa Rica, Latvia, Poland, and Chile) from 04 April 2022 to 25 October 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Crossover Atezolizumab IV/SC | Participants were administered atezolizumab, intravenous (IV) infusion, 1200 milligrams (mg), every 3 weeks (Q3W) for 3 cycles followed by atezolizumab, subcutaneous (SC) injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Crossover Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2024 | Oct 21, 2024 |
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| Cycles 3 Day 1 and Cycle 6 Day 1 (cycle length=21 days) |
| Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period | At Cycle 6, Day 1, participants were expected to select the route of study treatment administration (SC or IV) they would like to receive during the Treatment Continuation Period (starting at Cycle 7). Percentage of participants who chose SC administration have been reported here. Percentages have been rounded off. | Cycle 6 Day 1 (Cycle length=21 days) |
| Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area | The HCPQ- Drug Preparation Area Question 1 was completed by the HCPs within the pharmacy/drug preparation area where atezolizumab IV reconstitution or atezolizumab SC was prepared before the actual drug administration took place. The HCPQs were completed for every participant at each treatment cycle (Cycles 1-6, i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC or vice versa) of the treatment cross-over period. HCPs responded to the following parts of Question 1 that sought to evaluate the amount of time it took to prepare the IV infusion/SC injection of atezolizumab: "How long (in minutes) did it take to prepare the treatment for use?" | Day 1 of Cycles 1 to 6 (cycle length= 21 days) |
| Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area | HCPs within pharmacy/drug preparation area responded to HCPQ-Drug Preparation Area Question 2 at Cycle 6 of Treatment Crossover Period for every participant: "If all IV infusions are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a=Staff will have increased availability for other tasks in pharmacy; b=Administrative procedures around atezolizumab SC will require less time; c=Atezolizumab SC formulations will provide more flexibility for staff in managing their workload; d=Due to ready-to-use atezolizumab SC formulations, potential dosing errors will be avoided; e=Due to ready-to-use atezolizumab SC formulations, there will be less drug wastage; f=Without having to reconstitute the drug, less storage space for atezolizumab SC related supplies will be required in pharmacy; g=Preparation procedures & associated time staff time commitment will be reduced, h=It will ease drug administration for participants with difficult venous access." | Cycle 6 Day 1 (cycle length=21 days) |
| Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area | HCPs who prepared study treatment within the pharmacy/drug preparation area responded at to the following HCPQ-Drug Preparation Area Questions 3 and 4, at Cycle 6 of the Treatment Crossover Period for every participant: "Looking back over the Atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Question 4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The four available response options were: Atezolizumab IV, Atezolizumab SC, No Difference, and Missing. Percentages have been rounded off. | Cycle 6 Day 1 (cycle length= 21 days) |
| Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room | The HCPQ-Treatment Room Question 1 was completed for every participant at each treatment cycle of the Treatment Crossover Period (Cycles 1-6,i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC/vice versa) by HCPs who administered treatment to the study participants. HCPs responded to following parts of Question 1 that sought to evaluate the amount of time it took to complete activities related to treatment administration: "If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided (central venous catheter, peripherally inserted central catheter (PICC)/peripheral vein cannulation) & how long (in minutes) this took to set up (only for participants receiving IV treatment)? How long (in minutes) did it take to administer the treatment, i.e. total infusion duration? How long (in minutes) was the participant in the treatment room for in total?" Durations with non-zero HCP responders have been reported here. | Day 1 of Cycles 1 to 6 (cycle length=21 days) |
| Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room | HCPs who administered treatment responded to Question 2: If all IV are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a= Participants will be moved outside of infusion unit to receive SC injections (physician consultation room); b=Atezolizumab SC route will allow more flexible treatment scheduling; c=More participants will be treated in infusion unit; d=Waiting list for any IV treatment at infusion unit will be reduced; e=Staff resources will be re distributed to other departments of the hospital (less staffing required within infusion unit); f=There will still be sufficient interaction time between HCPs & participants (for participant education); g=Staff will spend more time for further professional education/development; h=Staff will dedicate more time to attending to administrative tasks for participants; i=Participants will spend less time in care unit; j=Administration by atezolizumab SC injection is preferred by participants. | Cycle 6 Day 1 (cycle length=21 days) |
| Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room | HCPs who administered study treatment responded at Cycle 6 of the Treatment Crossover Period to the following HCPQ-treatment room Questions 3 to 7: "Looking back over the atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Which method was most convenient for the participant? Question 4. Which method was best for optimizing participant care in your center? Question 5. Which method took the least time from start to finish of administration? Question 6. Which method required the least resource use for administration? Question 7. Which method was preferred by participants?" The five available response options were: Atezolizumab SC, Atezolizumab IV, No Difference, Unsure and Missing. Percentages have been rounded off. | Cycle 6 Day 1 (cycle length=21 days) |
| Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room | HCPs who administered study treatment responded at Cycle 6 of the treatment Cross-over Period to the following HCPQ-treatment room Question 8: How frequently would you offer or recommend atezolizumab SC administration to your participants in the future? The four available response options were Always, Sometimes, Never and Missing. Percentages have been rounded off. | Cycle 6 Day 1 (cycle length= 21 days) |
| Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The dyspnoea scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The insomnia scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The appetite loss scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The constipation scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The diarrhoea scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The financial difficulties scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom scales (fatigue, nausea and vomiting, pain), global health/ QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Q29: GHS; "How would you rate your overall health during the past week?") and QoL (Q30: QoL; "How would you rate your overall quality of life during the past week?") and were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome. | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
| Percentage of Participants With Ongoing Clinical Benefit | Participants were assessed for clinical benefit at every tumour assessment visit, which was conducted as per the local standard of care. Percentages have been rounded off. | Up to Cycle 16 (cycle length= 21 days) |
| Percentage of Participants With Adverse Events (AEs) | An AE is untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to the investigational product. Percentages have been rounded off. | Up to 90 days after the final dose of study drug (Up to 2.4 years) |
| Percentage of Participants With AEs During Treatment Cross-over Period | An AE is untoward medical occurrence in participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. The safety of switching from atezolizumab SC to atezolizumab IV and from atezolizumab IV to atezolizumab SC is being assessed in this outcome measure. Percentages have been rounded off. | From Cycle 1 Day 1 up to Cycle 3 Day 21; From Cycle 4 Day 1 up to Cycle 6 Day 21 (cycle length=21 days) |
| Massillon |
| Ohio |
| 44646-9128 |
| United States |
| Asante Rogue Regional Medical Center | Medford | Oregon | 97504-8332 | United States |
| UPMC - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | C1125ABD | Argentina |
| CEMIC | Buenos Aires | C1431FWN | Argentina |
| Centro Oncologico Korben | Ciudad Autonoma Buenos Aires | C1426AGE | Argentina |
| Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Royal Victoria Regional Health Centre | Barrie | Ontario | L4M 6M2 | Canada |
| Sault Area Hospital | Sault Ste. Marie | Ontario | P6B 0A8 | Canada |
| OrlandiOncología | Santiago | 7500713 | Chile |
| Clinica CIMCA | San José | 10103 | Costa Rica |
| ICIMED Instituto de Investigación en Ciencias Médicas | San José | 10108 | Costa Rica |
| Oulun yliopistollinen sairaala (OYS) | Oulu | 90220 | Finland |
| Tampereen yliopistollinen sairaala (TAYS) | Tampere | 33521 | Finland |
| Turun yliopistollinen keskussairaala (TYKS) | Turku | 20521 | Finland |
| Vaasan Keskussairaala | Vaasa | 65130 | Finland |
| Azienda Ospedaliera Universitaria Senese | Siena | Abruzzo | 53100 | Italy |
| IRCCS Istituto Regina Elena (IFO) | Rome | Lazio | 00144 | Italy |
| Instituto Europeo di Oncologia | Milan | Lombardy | 20141 | Italy |
| A.O.U. Maggiore della Carità | Novara | Piedmont | 28100 | Italy |
| Pauls Stradins Clinical University Hospital | R?ga | LV-1002 | Latvia |
| Riga East Clinical University Hospital Latvian Oncology Centre | Riga | LV-1079 | Latvia |
| Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie | Olsztyn | 10-357 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy | Otwock | 05-400 | Poland |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | LA Coruna | 15006 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Zaragoza | 50009 | Spain |
| Derived |
| Majem M, Chewaskulyong B, Zvirbule Z, Lee KH, Korbenfeld E, Kolb-Sielecki J, Castro Sanchez AY, Bustillos A, Herraez-Baranda L, Liu X, Kim SW, Cappuzzo F. Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer. Oncol Ther. 2026 Mar;14(1):313-326. doi: 10.1007/s40487-025-00402-x. Epub 2025 Nov 26. |
| Crossover Atezolizumab SC/IV |
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| FG002 | Continuation Atezolizumab IV | After 6 cycles of treatment in Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| FG003 | Continuation Atezolizumab SC | After 6 cycles of treatment in Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Continuation Period |
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Full analysis set (FAS) included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Crossover Atezolizumab IV/SC | Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for 3 cycles followed by atezolizumab, SC injections, 1875 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| BG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
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| Primary | Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ) | Participants preference was assessed based on the Question 1 of PPQ. Question 1 (All things considered, which route of administration did you prefer?) asks participants to report their preference for the route of administration (IV, SC, or no preference). A point estimate with associated 95% CI for the percentage of participants who preferred atezolizumab SC was calculated. Participants experiencing any of the following events: treatment withdrawal prior to eligibility for PPQ, or death without answering Question 1 of PPQ, or treatment not started; were excluded from the analysis set. Participants who answered Question 1 of the PPQ without having at least 2 consecutive administrations of treatment with each administration modality (SC and IV) were excluded from the analysis. Percentages have been rounded off. As planned, participant preference was summarized and presented by overall (all participants) and by randomized treatment sequence using FAS. | FAS included all randomized participants. Overall number analyzed is the number of participants who answered Question 1 of PPQ. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycle 6 Day 1 (cycle length=21 days) |
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| Secondary | Number of Participants by Their Level of Satisfaction With Atezolizumab SC and Atezolizumab IV Assessed Using Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) and Intravenous (TASQ-IV) | TASQ is a 12-item, participant-reported questionnaire measuring the impact of each mode of treatment administration (TASQ-IV for IV treatment and TASQ-SC for SC treatment) on five domains: Physical Impact, Psychological Impact, Impact on Activities of Daily Living, Convenience, and Satisfaction. TASQ-IV/-SC was administered at treatment Cycles 3 and 6 according to the order of treatment received per arm during the Crossover Period. Participants satisfaction was assessed based on the Question 1 of TASQ-IV/SC which asks participants about their satisfaction with respect to route of administration (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, participant did not answer the question). Question 1 - TASQ- IV (How satisfied or dissatisfied were you with the IV infusion?) and TASQ- SC (How satisfied or dissatisfied were you with the SC injection?) | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants who answered Question 1 of TASQ IV/SC. | Posted | Count of Participants | Participants | Cycles 3 Day 1 and Cycle 6 Day 1 (cycle length=21 days) |
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| Secondary | Percentage of Participants Who Select Atezolizumab SC for Treatment Continuation Period | At Cycle 6, Day 1, participants were expected to select the route of study treatment administration (SC or IV) they would like to receive during the Treatment Continuation Period (starting at Cycle 7). Percentage of participants who chose SC administration have been reported here. Percentages have been rounded off. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | percentage of participants | Cycle 6 Day 1 (Cycle length=21 days) |
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| Secondary | Duration of Treatment Preparation According to Healthcare Professionals (HCPs) Response to Perception of Time, Assessed Using Question 1 of Healthcare Professional Questionnaires (HCPQs) - Drug Preparation Area | The HCPQ- Drug Preparation Area Question 1 was completed by the HCPs within the pharmacy/drug preparation area where atezolizumab IV reconstitution or atezolizumab SC was prepared before the actual drug administration took place. The HCPQs were completed for every participant at each treatment cycle (Cycles 1-6, i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC or vice versa) of the treatment cross-over period. HCPs responded to the following parts of Question 1 that sought to evaluate the amount of time it took to prepare the IV infusion/SC injection of atezolizumab: "How long (in minutes) did it take to prepare the treatment for use?" | Overall number analyzed included HCPs who completed Question 1 of the survey. The number analyzed included HCPs who completed Question 1 of the survey at the specified treatment cycles. | Posted | Median | Full Range | minutes | Day 1 of Cycles 1 to 6 (cycle length= 21 days) |
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| Secondary | Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Drug Preparation Area | HCPs within pharmacy/drug preparation area responded to HCPQ-Drug Preparation Area Question 2 at Cycle 6 of Treatment Crossover Period for every participant: "If all IV infusions are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a=Staff will have increased availability for other tasks in pharmacy; b=Administrative procedures around atezolizumab SC will require less time; c=Atezolizumab SC formulations will provide more flexibility for staff in managing their workload; d=Due to ready-to-use atezolizumab SC formulations, potential dosing errors will be avoided; e=Due to ready-to-use atezolizumab SC formulations, there will be less drug wastage; f=Without having to reconstitute the drug, less storage space for atezolizumab SC related supplies will be required in pharmacy; g=Preparation procedures & associated time staff time commitment will be reduced, h=It will ease drug administration for participants with difficult venous access." | Overall number analyzed included HCPs who completed Question 2 of the survey at treatment Cycle 6. Percentages have been rounded off. | Posted | Number | percentage of HCPs | Cycle 6 Day 1 (cycle length=21 days) |
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| Secondary | Percentage of HCPs by Their Response to Perception of Time/Resource Use for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 and 4 of HCPQ - Drug Preparation Area | HCPs who prepared study treatment within the pharmacy/drug preparation area responded at to the following HCPQ-Drug Preparation Area Questions 3 and 4, at Cycle 6 of the Treatment Crossover Period for every participant: "Looking back over the Atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Was quickest from start to end of preparation to finish of administration (excluding observation period)?; Question 4. Required less resource use for preparation and administration, for example nursing time, facility costs, equipment etc?" The four available response options were: Atezolizumab IV, Atezolizumab SC, No Difference, and Missing. Percentages have been rounded off. | Overall number analyzed included HCPs who completed Questions 3 and 4 of the survey at treatment Cycle 6. | Posted | Number | percentage of HCPs | Cycle 6 Day 1 (cycle length= 21 days) |
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| Secondary | Duration of Treatment Administration Activities According to HCPs Response to Perception of Time, Assessed Using Question 1 of HCPQs - Treatment Room | The HCPQ-Treatment Room Question 1 was completed for every participant at each treatment cycle of the Treatment Crossover Period (Cycles 1-6,i.e., 3 cycles of atezolizumab IV followed by 3 cycles of atezolizumab SC/vice versa) by HCPs who administered treatment to the study participants. HCPs responded to following parts of Question 1 that sought to evaluate the amount of time it took to complete activities related to treatment administration: "If new IV access was needed for this cycle of treatment, please indicate what type of IV access was provided (central venous catheter, peripherally inserted central catheter (PICC)/peripheral vein cannulation) & how long (in minutes) this took to set up (only for participants receiving IV treatment)? How long (in minutes) did it take to administer the treatment, i.e. total infusion duration? How long (in minutes) was the participant in the treatment room for in total?" Durations with non-zero HCP responders have been reported here. | Overall number analyzed included HCPs who completed Question 1 of the survey. For the questions related to IV access, the number analyzed only includes number of HCP responders for participants who required new IV access at a given treatment cycle. The number analyzed included HCPs who completed Question 1 of the survey at the specified treatment cycles. Percentages have been rounded off. | Posted | Median | Full Range | minutes | Day 1 of Cycles 1 to 6 (cycle length=21 days) |
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| Secondary | Percentage of HCPs by Their Response to Perception of Impact on Clinical Management and Clinical Efficiency of Atezolizumab SC and IV, Assessed Using Question 2 of HCPQ - Treatment Room | HCPs who administered treatment responded to Question 2: If all IV are switched to SC, please indicate how strongly you agree/disagree with each of following statements: a= Participants will be moved outside of infusion unit to receive SC injections (physician consultation room); b=Atezolizumab SC route will allow more flexible treatment scheduling; c=More participants will be treated in infusion unit; d=Waiting list for any IV treatment at infusion unit will be reduced; e=Staff resources will be re distributed to other departments of the hospital (less staffing required within infusion unit); f=There will still be sufficient interaction time between HCPs & participants (for participant education); g=Staff will spend more time for further professional education/development; h=Staff will dedicate more time to attending to administrative tasks for participants; i=Participants will spend less time in care unit; j=Administration by atezolizumab SC injection is preferred by participants. | Overall number analyzed included HCPs who completed Question 2 of the survey at treatment Cycle 6. Percentages have been rounded off. | Posted | Number | percentage of HCPs | Cycle 6 Day 1 (cycle length=21 days) |
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| Secondary | Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 3 to 7 of HCPQ - Treatment Room | HCPs who administered study treatment responded at Cycle 6 of the Treatment Crossover Period to the following HCPQ-treatment room Questions 3 to 7: "Looking back over the atezolizumab treatment sessions, please indicate based on your opinion which administration method: Question 3. Which method was most convenient for the participant? Question 4. Which method was best for optimizing participant care in your center? Question 5. Which method took the least time from start to finish of administration? Question 6. Which method required the least resource use for administration? Question 7. Which method was preferred by participants?" The five available response options were: Atezolizumab SC, Atezolizumab IV, No Difference, Unsure and Missing. Percentages have been rounded off. | Overall number analyzed included HCPs who completed Questions 3 to 7 of the survey at treatment Cycle 6. | Posted | Number | percentage of HCPs | Cycle 6 Day 1 (cycle length=21 days) |
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| Secondary | Percentage of HCPs by Their Response to Perception of Time/Resource Use and Convenience for Atezolizumab SC and Atezolizumab IV, Assessed Using Questions 8 of HCPQ - Treatment Room | HCPs who administered study treatment responded at Cycle 6 of the treatment Cross-over Period to the following HCPQ-treatment room Question 8: How frequently would you offer or recommend atezolizumab SC administration to your participants in the future? The four available response options were Always, Sometimes, Never and Missing. Percentages have been rounded off. | Overall number analyzed included HCPs who completed Question 8 of the survey at treatment Cycle 6. | Posted | Number | percentage of HCPs | Cycle 6 Day 1 (cycle length= 21 days) |
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| Secondary | Change From Baseline Over Time in Physical Functioning Scale Score as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), global health status (GHS) and quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Role Functioning Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Emotional Functioning Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Cognitive Functioning Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Social Functioning Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The functioning items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating better functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Fatigue Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Nausea and Vomiting Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Pain Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The symptom items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Dyspnoea Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The dyspnoea scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Insomnia Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The insomnia scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Appetite Loss Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The appetite loss scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Constipation Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The constipation scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Diarrhoea Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The diarrhoea scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst symptoms. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Financial Difficulties Scale Score as Assessed by EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) with a recall period of the previous week. Scale scores can be obtained for the multi-item scales. The financial difficulties scale items are scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score on the scale indicating worst functioning. EORTC QLQ-C30 data was scored according to the EORTC scoring manual v3.0. In the event of incomplete data, if more than 50% of the constituent items were completed, a pro-rated score was computed. For subscales with less than 50% of the items completed, the subscale was considered as missing. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Change From Baseline Over Time in Health-related Quality of Life (HRQoL) Score as Assessed by GHS/QoL Scale of the EORTC-QLQ-C30 | EORTC QLQ-C30 consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom scales (fatigue, nausea and vomiting, pain), global health/ QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Q29: GHS; "How would you rate your overall health during the past week?") and QoL (Q30: QoL; "How would you rate your overall quality of life during the past week?") and were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoint. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 3, 6, 7, 10, 13, 16 and End of Treatment (up to approximately 2.2 years) |
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| Secondary | Percentage of Participants With Ongoing Clinical Benefit | Participants were assessed for clinical benefit at every tumour assessment visit, which was conducted as per the local standard of care. Percentages have been rounded off. | FAS included all randomized participants. Ongoing clinical benefit at Cycle 16 was summarized for overall participants, as due to switches in mode of administration up to Cycle 16, it would be impossible to isolate the effect of the randomization arms. Hence, per-arm data can't be presented. | Posted | Number | percentage of participants | Up to Cycle 16 (cycle length= 21 days) |
|
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| Secondary | Percentage of Participants With Adverse Events (AEs) | An AE is untoward medical occurrence in a participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to the investigational product. Percentages have been rounded off. | Safety evaluable population included all participants who received at least one dose of study treatment. | Posted | Number | percentage of participants | Up to 90 days after the final dose of study drug (Up to 2.4 years) |
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| Secondary | Percentage of Participants With AEs During Treatment Cross-over Period | An AE is untoward medical occurrence in participant administered a pharmaceutical product and regardless of causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. The safety of switching from atezolizumab SC to atezolizumab IV and from atezolizumab IV to atezolizumab SC is being assessed in this outcome measure. Percentages have been rounded off. | Safety evaluable population included all participants who received at least one dose of study treatment. In this analysis, participants were grouped by study arm and treatment period during the Crossover Period. | Posted | Number | percentage of participants | From Cycle 1 Day 1 up to Cycle 3 Day 21; From Cycle 4 Day 1 up to Cycle 6 Day 21 (cycle length=21 days) |
|
Up to 90 days after the final dose of study drug (Up to 2.4 years)
Safety evaluable population included all participants who received at least one dose of study treatment. As pre-planned, adverse events are presented for IV and SC administration of atezolizumab for each study period (crossover and continuation) and overall for all participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Crossover Atezolizumab IV | Participants who were administered atezolizumab, IV infusion, 1200 mg, Q3W in Cycles 1 to 3 or Cycles 4 to 6 (cycle length=21 days), depending on the sequence (IV/SC or SC/IV) they were assigned in the Treatment Crossover Period are reported in this arm. | 16 | 160 | 15 | 160 | 60 | 160 |
| EG001 | Crossover Atezolizumab SC | Participants who were administered atezolizumab, SC injections, 1875 mg, Q3W for Cycles 1 to 3 or Cycles 4 to 6 (cycle length=21 days), depending on the sequence (IV/SC or SC/IV) they were assigned in the Treatment Crossover Period are reported in this arm. | 21 | 155 | 13 | 155 | 52 | 155 |
| EG002 | Continuation Atezolizumab IV | Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. | 5 | 26 | 6 | 26 | 16 | 26 |
| EG003 | Continuation Atezolizumab SC | Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. | 12 | 89 | 12 | 89 | 44 | 89 |
| EG004 | All Participants | This arm includes all participants who were administered atezolizumab IV, 1200 mg, and/or SC, 1875 mg Q3W up to Cycle 16 in the Treatment Crossover Period and Treatment Continuation Period for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. | 54 | 175 | 45 | 175 | 172 | 175 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Autoimmune myocarditis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myasthenia gravis | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 8, 2023 | Oct 21, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| Death |
|
| Disease Relapse |
|
| Lack of Efficacy |
|
| Physician Decision |
|
| Progressive Disease |
|
| Study Ended by Sponsor |
|
| Symptomatic Deterioration |
|
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
|
|
| Participants |
|
|
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. HCPs who prepared and/or administered the IV/SC formulations completed the HCPQ questionnaire. |
|
|
| OG001 | Atezolizumab SC/ IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. HCPs who prepared and/or administered the IV/SC formulations completed the HCPQ questionnaire. |
|
|
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. HCPs who prepared and/or administered the IV/SC formulations completed the HCPQ questionnaire.
|
|
| OG001 | Atezolizumab SC/ IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. HCPs who prepared and/or administered the IV/SC formulations completed the HCPQ questionnaire. |
|
|
| OG001 | Atezolizumab SC/ IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. HCPs who prepared and/or administered the IV/SC formulations completed the HCPQ questionnaire. |
|
|
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. HCPs who prepared and/or administered the IV/SC formulations completed the HCPQ questionnaire. |
|
|
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 |
| Crossover Atezolizumab SC/IV |
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 |
| Crossover Atezolizumab SC/IV |
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG001 | Crossover Atezolizumab SC/IV | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| Crossover Atezolizumab SC/IV |
Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for 3 cycles followed by atezolizumab, IV, 1200 mg, Q3W, for the next 3 cycles (cycle length=21 days) in the Treatment Crossover Period. |
| OG002 | Continuation Atezolizumab IV | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | After 6 cycles of Crossover Period, participants were given an option to choose between IV or SC administration of atezolizumab for the Treatment Continuation Period. Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
|
| Continuation Atezolizumab IV |
Participants in this arm chose to continue treatment with atezolizumab IV, 1200 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
| OG003 | Continuation Atezolizumab SC | Participants in this arm chose to continue treatment with atezolizumab SC, 1875 mg Q3W up to Cycle 16 for participants with early-stage NSCLC or until loss of clinical benefit for participants with advanced NSCLC. |
|
|
| OG002 | Atezolizumab SC/IV (Cycles 1 to 3) | Participants were administered atezolizumab, SC injections, 1875 mg, Q3W for Cycles 1 to 3 (cycle length=21 days) of the Treatment Crossover Period. |
| OG003 | Atezolizumab SC/IV (Cycles 4 to 6) | Participants were administered atezolizumab, IV infusion, 1200 mg, Q3W for Cycles 4 to 6 (cycle length=21 days) of the Treatment Crossover Period. |
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