Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002328-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab (Part 2) | Experimental | Atezolizumab |
|
| Cohort 1: Atezolizumab+rHuPH20 (Part 1) | Experimental | Atezolizumab+recombinant human hyaluronidase (rHuPH20), followed by Atezolizumab |
|
| Cohort 2: Atezolizumab+rHuPH20 (Part 1) | Experimental | Atezolizumab+rHuPH20, followed by Atezolizumab |
|
| Cohort 3: Atezolizumab+rHuPH20(Part 1) | Experimental | Atezolizumab+rHuPH20, followed by Atezolizumab |
|
| Atezolizumab + rHuPH20 (Part 2) | Experimental | Atezolizumab + rHuPH20 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered as per the schedule specified in arm or cohort. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1 | Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2) | |
| Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1 | Predose on Day 1 of Cycle 2 (Cycle length =21 days) | |
| Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1 | From start of dosing up to Day 21 in Cycle 1 (Cycle length = 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab | Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2) | |
| Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab |
Not provided
Inclusion Criteria:
Additional Inclusion Criteria (Part 2 Only) • Availability of tissue and known epidermal growth factor receptor (EGFR) status
Exclusion Criteria:
Additional Exclusion Criteria (Part 2 Only)
• Tested tumor programmed death-ligand-1 (PD-L1) expression status with an intention to treat the patient if positive
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | C1125ABD | Argentina | |||
| Centro Oncologico Riojano Integral (CORI) |
| 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. | |
| 38729426 |
Not provided
Not provided
Study consisted of 2 parts: Part 1 (Dose Finding) & Part 2 (Dose Confirmation). Health care professionals (HCPs) who administered the study treatment to participants were not enrolled in the study. To evaluate the HCPs' reported experience with administration of atezolizumab SC & atezolizumab IV, the HCPs were asked to complete two questionnaires: 'HCP SC Versus IV Perspective' & 'HCP SC Perspective'.
No data other than the HCP's responses to these Questionnaires were collected in this study.
A total of 438 participants with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) who were cancer immunotherapy (CIT)-naïve and for whom prior platinum-based therapy failed took part in the study across 23 countries from 27 December 2018 to 22 November 2024. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Participants received atezolizumab, 1800 milligrams (mg), co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, every 3 weeks (Q3W) on Day 1 of subsequent cycles (1 cycle=21 days) until disease progression (PD), loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2023 | Apr 25, 2023 |
Not provided
Intervention study model can be sequential or in parallel.
Not provided
Not provided
Not provided
Not provided
|
| rHuPH20 | Drug | rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1. |
|
|
| Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2) |
| Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab | Predose and up to 21 days post dose in Cycle 1 for cohorts 1 and 3 and from predose up to 14 days post last dose in Cycle 1 for cohort 2 (Cycle length= 21 days for cohorts 1 and 3 and 14 days for cohort 2) |
| Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C. | Cohort 1: Predose: D1 & postdose: D1, 3, 8 of C1; Cohort 2: Pre & postdose: D1 of C1, 3 & postdose: D3, 8 of C1, Predose: D1 of C2; Cohort 3: Pre & postdose: D1 of C1, 2 & postdose: D3, 8 of C1, D2, 4 & 9 of C2 & pre dose: D1 of C3 |
| Part 1: Percentage of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0). Percentages have been rounded to one decimal place. | From initiation of study treatment up to approximately 69 months |
| Part 2: Percentage of Participants With AEs | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, V5.0. Percentages have been rounded to one decimal place. | From initiation of study treatment up to approximately 44.7 months |
| Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1 | Cycle 1 (Cycle length=21 days) |
| Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab | 1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo. | Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months) |
| Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab | 1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo | Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months) |
| Part 2: Objective Response Rate (ORR) | ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD in the absence of CR. Percentage of participants who achieved confirmed objective response (CR or PR) have been reported. Percentages have been rounded to one decimal place. | Up to approximately 25 months |
| Part 2: Progression-free Survival (PFS) | PFS was defined as the time from study start to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was analyzed using the Kaplan-Meier method. | Up to approximately 25 months |
| Part 2: Overall Survival (OS) | OS was defined as the time from the date of study randomization to the date of death from any cause. | Up to approximately 44.7 months |
| Part 2: Duration of Response (DOR) | DOR was defined as the time from first occurrence of a documented confirmed objective response (CR or PR) to PD as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SODs must also demonstrate an absolute increase of ≥ 5 mm. | Up to approximately 25 months |
| Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | EORTC IL57 questionnaire has 10 items and covers 3 scales: physical functioning (PF), role functioning (RF) & global health status/quality of life (GHS/QoL) & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning & a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome. | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months) |
| Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning & a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome. | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months) |
| Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning & a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome. | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months) |
| Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ) | Modified SWT scale of the CTSQ consisted of seven items that measured seven domains related to satisfaction with cancer therapy. These include worthwhile, difficulty, benefits, feelings about side effects, form of therapy, overall satisfaction, and if participants would choose the therapy taking everything into consideration. Each domain is rated on a 5-point scale, with 1 representing the worst response and 5 representing the best response, except in the case of one reverse-scored item. Mean of the items were linearly transformed to obtain scores from 0-100, where 100 was the best possible score. Higher scores indicate higher satisfaction. Here, data for 'overall satisfaction' domain has been presented. | Day 1 Cycle 3 or Treatment Discontinuation Visit (if treatment discontinued at any visit before Cycle 3) (Cycle length = 21 days) |
| Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | The overall patient-reported AE burden was assessed using a single item from the EORTC IL57 questionnaire i.e "To what extent have you been troubled with side-effects from your treatment?" The questions were answered on a 4-point Likert scale, where 1="Not at all" to 4="Very much". Higher scores indicated greater AE burden. Percentages have been rounded to one decimal place. | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, and 64 (Cycle length = 21 days) |
| Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration | The percentage of ADA-positive participants after atezolizumab administration was reported. Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place. | From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months) |
| Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration | The percentage of ADA-positive participants after atezolizumab SC formulated with rHuPH20 administration was reported. Participants who received atezolizumab SC formulated with rHuPH20 were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following rHuPH20 exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place. | From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months) |
| Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire | The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Which formulation of atezolizumab (SC or IV) do you think is more convenient for you? Responses to this question are reported in the data table. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'first participant in [FPI]' date to 'last participant last visit [LPLV]' for Part 2). | After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months) |
| Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire | The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: If used in routine practice, do you think administering atezolizumab SC could save staff time compared to atezolizumab IV? The responses to this question could be Yes; No; Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). | After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months) |
| Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire | The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, were you more satisfied with atezolizumab SC or atezolizumab IV? The responses included: More satisfied with atezolizumab SC; Equally satisfied with both formulations; More satisfied with atezolizumab IV. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). | After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months) |
| Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire | The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Do you think atezolizumab SC is convenient? The responses to this question could be: Yes; No; and Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place. | After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months) |
| Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire | The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: Overall, how easy did you find atezolizumab SC administration? The responses to this question could be: Very easy; Fairly easy; Not at all easy. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place. | After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months) |
| Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire | The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, how satisfied were you with atezolizumab SC? The responses to this question could be: Very satisfied; Satisfied; Dissatisfied; Very dissatisfied. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place. | After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months) |
| La Rioja |
| F5300COE |
| Argentina |
| Consultorio Dr. Miguel Angel Escudero | Salta | 4400 | Argentina |
| Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda | Ijuí | Rio Grande do Sul | 98700-000 | 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 |
| INCA 1- Instituto Nacional de Câncer X | Rio de Janeiro | 20231-050 | Brazil |
| Bradford Hill Centro de Investigaciones Clinicas | Recoleta | 8420383 | Chile |
| James Lind Centro de Investigación Del Cáncer | Temuco | 4800827 | Chile |
| Oncocentro Apys | Viña del Mar | 2520598 | Chile |
| Jilin Cancer Hospital | Changchun | 132013 | China |
| West China Hospital - Sichuan University | Chengdu | 610047 | China |
| Sir Run Run Shaw Hospital Zhejiang University | Hangzhou | 310016 | China |
| Jinan Central Hospital | Jinan | 250013 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Clinica CIMCA | San José | 10103 | Costa Rica |
| ICIMED Instituto de Investigación en Ciencias Médicas | San José | 10108 | Costa Rica |
| APHM | Marseille | 13385 | France |
| Ico Rene Gauducheau | Saint-Herblain | 44805 | France |
| General Hospital "G.Papanikolaou" | Asvestochóri | 570 10 | Greece |
| Sotiria Hospital | Athens | 104 31 | Greece |
| INTEGRA Cancer Institute | Guatemala City | 01010 | Guatemala |
| Oncomedica | Guatemala City | 01010 | Guatemala |
| Grupo Angeles | Guatemala City | 01015 | Guatemala |
| Hospital El Pilar | Guatemala City | 01015 | Guatemala |
| Matrai Gyogyintezet | Mátraháza | 3233 | Hungary |
| Református Pulmonológiai Centrum | Törökbálint | 2045 | Hungary |
| Asst Papa Giovanni XXIII | Bergamo | Lombardy | 24128 | Italy |
| IRCCS Istituto Clinico Humanitas | Rozzano | Lombardy | 20089 | Italy |
| Riga East Clinical University Hospital Latvian Oncology Centre | Riga | LV-1079 | Latvia |
| Health Pharma Professional Research | Mexico City | Mexico CITY (federal District) | 03100 | Mexico |
| Cuidados oncologicos | Querétaro City | Querétaro | 76000 | Mexico |
| Auckland City Hospital, Cancer and Blood Research | Auckland | 1023 | New Zealand |
| Christchurch Clinical Studies Trust Ltd | Christchurch | New Zealand |
| Waikato Hospital - Cancer and Blood Research Trials Unit | Hamilton | 3204 | New Zealand |
| Tauranga Hospital, Clinical Trials Unit | Tauranga | 3112 | New Zealand |
| Centro Medico Monte Carmelo | Arequipa | 04001 | Peru |
| Clínica San Gabriel | Lima | 15088 | Peru |
| Oncosalud Sac | Lima | 41 | Peru |
| Clinica Internacional, Sede San Borja | Lima | Lima 41 | Peru |
| Regionalny Szpital Specjalistyczny im. W. Bieganskiego | Grudzi?dz | 86-300 | Poland |
| Centrum Terapii Wspolczesnej | Lodz | 93-319 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy | Otwock | 05-400 | Poland |
| Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie | Warsaw | 02-781 | Poland |
| Chelyabinsk Regional Clinical Oncology Dispensary | Chelyabinsk | Moscow Oblast | 454087 | Russia |
| FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF | Moscow | Moscow Oblast | 115478 | Russia |
| MEDSI Clinical Hospital on Pyatnitsky Highway | Moscow | Moscow Oblast | 143422 | Russia |
| Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod | Nizhny Novgorod | Niznij Novgorod | 603081 | Russia |
| Mordovia State University | Saransk | Respublika Mordoviya | 430032 | Russia |
| SBIH Kaluga Region Clinical Oncology Dispensary | Kaluga | 248007 | Russia |
| Murmansk Regional Clinical Hospital named after P.A. Bayandin | Murmansk | 183047 | Russia |
| Multidisciplinary clinic Reaviz | Samara | 443011 | Russia |
| Groote Schuur Hospital ( Uni of Capetown ) | Cape Town | 7506 | South Africa |
| Wilgers Oncology Centre | Pretoria | 0001 | South Africa |
| Sandton Oncology Medical Group | Sandton | 2196 | South Africa |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Centre | Seoul | 135-170 | South Korea |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Vajira Hospital | Bangkok | 10300 | Thailand |
| Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| Faculty of Med. Siriraj Hosp. | Bangkok | 10700 | Thailand |
| Prapokklao Hospital | Chanthaburi | 22000 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | 50200 | Thailand |
| Prince of Songkla University | Hat Yai | 90110 | Thailand |
| Udonthani Cancer Hospital, Udonthani | Muang,Udonthani | 41330 | Thailand |
| Medipol University Medical Faculty | Istanbul | 34214 | Turkey (Türkiye) |
| Ege Uni Medical Faculty Hospital | Izmir | 35100 | Turkey (Türkiye) |
| Municipal Institution City Clinical Hospital #4 of Dnipro City Council | Dnipropetrovsk | Katerynoslav Governorate | 49102 | Ukraine |
| Communal Non profit Enterprise Regional Center of Oncology | Kharkiv | Kharkiv Governorate | 61070 | Ukraine |
| Ivano-Frankivsk Regional Oncology Center | Ivano-Frankivsk | 76018 | Ukraine |
| RCI Sumy Regional Clinical Oncological Dispensary | Sumy | 40005 | Ukraine |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Derived |
| Burotto M, Zvirbule Z, Alvarez R, Chewaskulyong B, Herraez-Baranda LA, Shearer-Kang E, Liu X, Tosti N, Williams P, Castro Sanchez AY, Zanghi J, Felip E. Brief Report: Updated Data From IMscin001 Part 2, a Randomized Phase III Study of Subcutaneous Versus Intravenous Atezolizumab in Patients With Locally Advanced or Metastatic NSCLC. J Thorac Oncol. 2024 Oct;19(10):1460-1466. doi: 10.1016/j.jtho.2024.05.005. Epub 2024 May 9. |
| 37268157 | Derived | Burotto M, Zvirbule Z, Mochalova A, Runglodvatana Y, Herraez-Baranda L, Liu SN, Chan P, Shearer-Kang E, Liu X, Tosti N, Zanghi JA, Leutgeb B, Felip E. IMscin001 Part 2: a randomised phase III, open-label, multicentre study examining the pharmacokinetics, efficacy, immunogenicity, and safety of atezolizumab subcutaneous versus intravenous administration in previously treated locally advanced or metastatic non-small-cell lung cancer and pharmacokinetics comparison with other approved indications. Ann Oncol. 2023 Aug;34(8):693-702. doi: 10.1016/j.annonc.2023.05.009. Epub 2023 Jun 1. |
| 33788415 | Derived | Felip E, Burotto M, Zvirbule Z, Herraez-Baranda LA, Chanu P, Kshirsagar S, Maiya V, Chan P, Pozzi E, Marchand M, Monchalin M, Tanaka K, Tosti N, Wang B, Restuccia E. Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1142-1155. doi: 10.1002/cpdd.936. Epub 2021 Mar 31. |
| FG001 | Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
| FG002 | Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
| FG003 | Part 2: Atezolizumab IV 1200 mg | Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. |
| FG004 | Part 2: Atezolizumab SC 1875 mg | Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Part 1: Intent-to-treat (ITT) population included all enrolled participants. Part 2: Full analysis set (FAS) included all participants who were randomized with participants grouped per their assigned treatment.
HCPs who administered the study treatment to participants were not enrolled in the study. To evaluate the HCPs' reported experience with administration of atezolizumab SC & IV, the HCPs were asked to complete 2 questionnaires. No baseline data were collected for the HCPs in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
| BG001 | Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
| BG002 | Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
| BG003 | Part 2: Atezolizumab IV 1200 mg | Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. |
| BG004 | Part 2: Atezolizumab SC 1875 mg | Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Serum Trough Concentration (Ctrough) of Atezolizumab at Cycle 1 | Pharmacokinetic (PK)-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Pre-dose on Day 1 of Cycle 2 (Cycle length=21 days for cohorts 1 and 3 and 14 days for cohort 2) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Part 2: Observed Serum Ctrough of Atezolizumab at Cycle 1 | Per Protocol PK evaluable population included all participants randomized to the atezolizumab SC and atezolizumab IV treatment arms who did not have protocol deviations that could affect Cycle 1 observed Ctrough results. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Predose on Day 1 of Cycle 2 (Cycle length =21 days) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Part 2: Area Under the Concentration-Time Curve From Time Zero to 21 Days (AUC 0-21 d) at Cycle 1 | PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms day per mL (μg*day/mL) | From start of dosing up to Day 21 in Cycle 1 (Cycle length = 21 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Part 1: Maximum Observed Serum Concentration (Cmax) of Atezolizumab | PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Time to Maximum Serum Concentration (Tmax) of Atezolizumab | PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | Full Range | days | Predose and post dose on Day 1 of Cycle 1 and post dose on Days 3 and 8 of Cycle 1 (Cycle length = 21 days for cohorts 1 and 3 and 14 days for cohort 2) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Area Under the Concentration-time Curve (AUClast) of Atezolizumab | PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg*day/mL | Predose and up to 21 days post dose in Cycle 1 for cohorts 1 and 3 and from predose up to 14 days post last dose in Cycle 1 for cohort 2 (Cycle length= 21 days for cohorts 1 and 3 and 14 days for cohort 2) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 1: Serum Atezolizumab Concentration at Specified Timepoint During SC Administration | Cycle length =21 days for cohorts 1 and 3 and 14 days for cohort 2. Day=D; Cycle=C. | PK-evaluable population included all participants who received at least one dose of atezolizumab and had at least 1 evaluable post dose PK sample that could affect PK results. 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 a given timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cohort 1: Predose: D1 & postdose: D1, 3, 8 of C1; Cohort 2: Pre & postdose: D1 of C1, 3 & postdose: D3, 8 of C1, Predose: D1 of C2; Cohort 3: Pre & postdose: D1 of C1, 2 & postdose: D3, 8 of C1, D2, 4 & 9 of C2 & pre dose: D1 of C3 |
| |||||||||||||||||||||||||||||||||
| Secondary | Part 1: Percentage of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 5.0 (NCI-CTCAE, v5.0). Percentages have been rounded to one decimal place. | Safety-evaluable population included all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received. | Posted | Number | percentage of participants | From initiation of study treatment up to approximately 69 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of Participants With AEs | An AE was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, V5.0. Percentages have been rounded to one decimal place. | Safety-evaluable population included all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received. | Posted | Number | percentage of participants | From initiation of study treatment up to approximately 44.7 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Model Predicted Ctrough of Atezolizumab at Cycle 1 | PK evaluable population included all participants randomized to the atezolizumab SC and atezolizumab IV treatment arms with at least one post-baseline PK sample. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Cycle 1 (Cycle length=21 days) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Model Predicted Ctrough at Steady State (Ctrough,ss) of Atezolizumab | 1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo. | PK-evaluable population included all participants who received at least one dose of atezolizumab (atezolizumab SC or atezolizumab IV) and had at least 1 evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Model Predicted AUC at Steady State (AUCss) of Atezolizumab | 1 cycle=21 days Abbreviations used-Cycle=C; Day =D; Atezolizumab=atezo | PK-evaluable population included all participants who received at least one dose of atezolizumab (atezolizumab SC or atezolizumab IV) and had at least 1 evaluable post dose PK sample. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | ug*day/mL | Atezo SC: Pre&postdose C1D1, postdose C1 Days 2,4,8, Pre&postdose C2,D1 and Predose on D1 of C3,4,8,12 and 16 ; Atezo IV: Pre&postdose on C1D1, postdose C1 Days 2,4,8; Pre&postdose C2D1, Predose on D1 of C3,4,8,12, and 16 (up to approximately 16 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Objective Response Rate (ORR) | ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1). CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD in the absence of CR. Percentage of participants who achieved confirmed objective response (CR or PR) have been reported. Percentages have been rounded to one decimal place. | Response-evaluable population included all participants with measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 25 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Progression-free Survival (PFS) | PFS was defined as the time from study start to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was analyzed using the Kaplan-Meier method. | FAS included all randomized participants, with participants grouped according to their assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 25 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Part 2: Overall Survival (OS) | OS was defined as the time from the date of study randomization to the date of death from any cause. | FAS included all randomized participants, with participants grouped according to their assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 44.7 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Part 2: Duration of Response (DOR) | DOR was defined as the time from first occurrence of a documented confirmed objective response (CR or PR) to PD as determined by the investigator according to RECIST v1.1. or death from any cause, whichever occurs first. CR was defined as the disappearance of all target lesions and any pathological lymph nodes must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). In addition to the relative increase of 20%, the SODs must also demonstrate an absolute increase of ≥ 5 mm. | DOR-evaluable population included all participants with a measurable disease at baseline and a post-baseline confirmed objective response (CR or PR). | Posted | Median | 95% Confidence Interval | months | Up to approximately 25 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL) 57 Physical Functioning Score | EORTC IL57 questionnaire has 10 items and covers 3 scales: physical functioning (PF), role functioning (RF) & global health status/quality of life (GHS/QoL) & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning & a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome. | FAS included all randomized participants, with participants grouped according to their assigned treatment. 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 the specified time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in EORTC IL57 Role Functioning Score | EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning & a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome. | FAS included all randomized participants, with participants grouped according to their assigned treatment. 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 the specified time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Change From Baseline in EORTC IL57 Global Health Status Score | EORTC IL57 questionnaire has 10 items and covers 3 scales: PF, RF & GHS/QoL & 1 item from EORTC IL. PF scale has 5 items evaluating the extent to which participants have trouble doing strenuous activities; taking long walks & short walks; need to stay in bed or a chair; need help with eating, dressing, bathing/using toilet. RF scale has 2 items evaluating extent to which participants are limited in doing work & pursuing leisure activities in previous week. GHS/QoL scale has 2 items evaluating participants' overall health & QoL in previous week. Questions are answered on a 4-point Likert scale (where 1="Not at all" to 4="Very much") for physical and role functioning & a 7-point scale (where 1="Very poor" to 7="Excellent") for GHS/QoL. For each scale, mean of the items are linearly transformed to obtain scores from 0-100, where 100 = best possible score. Higher score indicates better outcome. | FAS included all randomized participants, with participants grouped according to their assigned treatment. 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 the specified time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64 (Cycle length = 21 days), and Treatment Discontinuation Visit (up to approximately 44 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Overall Satisfaction With Treatment Over Time, Assessed by the Modified Satisfaction With Therapy (SWT) Scale of the Cancer Therapy Satisfaction Questionnaire (CTSQ) | Modified SWT scale of the CTSQ consisted of seven items that measured seven domains related to satisfaction with cancer therapy. These include worthwhile, difficulty, benefits, feelings about side effects, form of therapy, overall satisfaction, and if participants would choose the therapy taking everything into consideration. Each domain is rated on a 5-point scale, with 1 representing the worst response and 5 representing the best response, except in the case of one reverse-scored item. Mean of the items were linearly transformed to obtain scores from 0-100, where 100 was the best possible score. Higher scores indicate higher satisfaction. Here, data for 'overall satisfaction' domain has been presented. | FAS included all randomized participants, with participants grouped according to their assigned treatment. 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 the specified time point. | Posted | Mean | Standard Deviation | score on a scale | Day 1 Cycle 3 or Treatment Discontinuation Visit (if treatment discontinued at any visit before Cycle 3) (Cycle length = 21 days) |
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of Participants by Their Responses to AE's Burden Over Time, Assessed by the Treatment-related Symptom Burden Item From the EORTC IL57 | The overall patient-reported AE burden was assessed using a single item from the EORTC IL57 questionnaire i.e "To what extent have you been troubled with side-effects from your treatment?" The questions were answered on a 4-point Likert scale, where 1="Not at all" to 4="Very much". Higher scores indicated greater AE burden. Percentages have been rounded to one decimal place. | FAS included all randomized participants, with participants grouped according to their assigned treatment. 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 the specified time point. | Posted | Number | percentage of participants | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, and 64 (Cycle length = 21 days) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of Participants With Ant-Drug Antibodies (ADAs) to Atezolizumab After SC or IV Administration | The percentage of ADA-positive participants after atezolizumab administration was reported. Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place. | Safety-evaluable population included all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | percentage of participants | From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of Participants With ADAs to rHuPH20 After SC Administration | The percentage of ADA-positive participants after atezolizumab SC formulated with rHuPH20 administration was reported. Participants who received atezolizumab SC formulated with rHuPH20 were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following rHuPH20 exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Percentages have been rounded to one decimal place. | Safety-evaluable population included all participants who received at least one dose of atezolizumab SC formulated with rHuPH20. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | percentage of participants | From Cycle 1 Day 1 (Cycle length = 21 days) up to treatment discontinuation visit (Up to approximately 20 months) |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of Health Care Professionals (HCPs) by Their Response to Question 2 of HCP SC Versus IV Perspective Questionnaire | The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Which formulation of atezolizumab (SC or IV) do you think is more convenient for you? Responses to this question are reported in the data table. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'first participant in [FPI]' date to 'last participant last visit [LPLV]' for Part 2). | Overall number analyzed included HCPs who completed Question 2 of the questionnaire. | Posted | Number | percentage of HCPs | After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Versus IV Perspective Questionnaire | The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: If used in routine practice, do you think administering atezolizumab SC could save staff time compared to atezolizumab IV? The responses to this question could be Yes; No; Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). | Overall number analyzed included HCPs who completed Question 3 of the questionnaire. | Posted | Number | percentage of HCPs | After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Versus IV Perspective Questionnaire | The HCP SC versus IV Perspective Questionnaire consisted of five items evaluating the number of atezolizumab SC and IV administrations done, convenience, potential time savings, and overall satisfaction with atezolizumab SC and atezolizumab IV, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as an IV infusion and as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, were you more satisfied with atezolizumab SC or atezolizumab IV? The responses included: More satisfied with atezolizumab SC; Equally satisfied with both formulations; More satisfied with atezolizumab IV. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). | Overall number analyzed included HCPs who completed Question 4 of the questionnaire. | Posted | Number | percentage of HCPs | After HCP has completed administering at least 3 doses of atezolizumab SC and IV across all participants in Part 2 (Up to approximately 48 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of HCPs by Their Response to Question 2 of the HCP SC Perspective Questionnaire | The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 2 is being reported here: Question 2: Do you think atezolizumab SC is convenient? The responses to this question could be: Yes; No; and Unsure. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place. | Overall number analyzed included HCPs who completed Question 2 of the questionnaire. | Posted | Number | percentage of HCPs | After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of HCPs by Their Response to Question 3 of the HCP SC Perspective Questionnaire | The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 3 is being reported here: Question 3: Overall, how easy did you find atezolizumab SC administration? The responses to this question could be: Very easy; Fairly easy; Not at all easy. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place. | Overall number analyzed included HCPs who completed Question 3 of the questionnaire. | Posted | Number | percentage of HCPs | After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months) |
| ||||||||||||||||||||||||||||||||||
| Secondary | Part 2: Percentage of HCPs by Their Response to Question 4 of the HCP SC Perspective Questionnaire | The HCP SC Perspective Questionnaire consisted of five items evaluating the convenience, ease of administration and overall satisfaction with atezolizumab SC, as well as reasons for HCP-reported satisfaction or dissatisfaction. HCPs who administered at least three doses of atezolizumab as a SC injection across all participants in Part 2 of this study responded to this questionnaire, of which question 4 is being reported here: Question 4: Overall, how satisfied were you with atezolizumab SC? The responses to this question could be: Very satisfied; Satisfied; Dissatisfied; Very dissatisfied. HCPs were allowed to complete the questionnaire until the last participant completed their assessments (duration between the 'FPI in' date to 'LPLV' for Part 2). Percentages have been rounded to one decimal place. | Overall number analyzed included HCPs who completed Question 4 of the questionnaire. | Posted | Number | percentage of HCPs | After HCP has completed administering at least 3 doses of atezolizumab SC across all participants in Part 2 (Up to approximately 48 months) |
|
From initiation of the study treatment up to approximately 69 months in Part 1 and up to approximately 44.7 months in Part 2
Safety-evaluable population=all participants who received at least one dose of atezolizumab (IV or SC), with participants grouped according to treatment received.
HCPs who administered study treatment to participants were not enrolled in the study. To evaluate the HCPs' reported experience with administration of atezolizumab SC & IV, they were asked to complete 2 questionnaires: HCP SC Versus IV Perspective & HCP SC Perspective. No adverse event data were collected for the HCPs in this study.
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 | Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg | Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. | 4 | 13 | 2 | 13 | 13 | 13 |
| EG001 | Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg | Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. | 6 | 15 | 4 | 15 | 12 | 15 |
| EG002 | Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. | 19 | 39 | 8 | 39 | 31 | 39 |
| EG003 | Part 2: Atezolizumab IV 1200 mg | Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. | 97 | 124 | 35 | 124 | 91 | 124 |
| EG004 | Part 2: Atezolizumab SC 1875 mg | Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. | 206 | 247 | 50 | 247 | 204 | 247 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Autoimmune myocarditis | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Drug reaction with eosinophilia and systemic symptoms | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Toxic epidermal necrolysis | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| Lack of injection site rotation | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood sodium decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hair follicle tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Sensory loss | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA version 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 | Hoffman-La-Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2022 | Apr 25, 2023 | SAP_001.pdf |
Not provided
| 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
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Not Stated |
|
| Unknown |
|
|
|
|
|
Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
|
|
Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
|
|
| Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg |
Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
|
|
| OG002 | Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
|
|
Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
| OG002 | Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg | Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. |
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. |
| OG001 | Part 2: Atezolizumab SC 1875 mg | Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. |
|
|
| OG001 | Part 2: Atezolizumab SC 1875 mg | Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. |
|
|
| OG001 | Part 2: Atezolizumab SC 1875 mg | Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. |
|
|
| Part 2: Atezolizumab SC 1875 mg |
Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|