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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004773-29 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Tiragolumab | Experimental | Participants will receive atezolizumab administered intravenously (IV) on Day 1 of each 28-day cycle followed by tiragolumab administered IV on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
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| Durvalumab | Active Comparator | Participants will receive durvalumab administered IV during each 28-day cycle for a maximum of 13 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS) | PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions. Kaplan-Meier (K-M) method was used to estimate median PFS. | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
| PFS, as Assessed by an IRF in FAS | PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS. | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in PPAS | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. | From randomization to death from any cause (up to approximately 57 months) |
| PFS, as Assessed by the Investigator in PPAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States | ||
| Banner MD Anderson Cancer Center |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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Participants were randomized in a 1:1 ratio to receive either durvalumab or atezolizumab plus tiragolumab in the consolidation setting. The study is considered "Completed" as all the pre-planned study activities and analyses have been performed.
A total of 829 participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC), who had previously received concurrent platinum-based chemoradiotherapy (CRT) without disease progression (PD), took part in the study at 189 investigative sites across 26 countries from 24 August 2020 to 31 July 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Durvalumab | Participants received durvalumab, 10 milligrams per kilogram (mg/kg), intravenously (IV), on Days 1 and 15 of each 28-day cycle or 1500 milligrams (mg) (for participants weighing ≥ 30 kilograms [kg]), IV on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
| FG001 | Atezolizumab + Tiragolumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 26, 2023 | May 7, 2026 |
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| Tiragolumab | Drug | Tiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle. |
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| Durvalumab | Drug | Durvalumab will be administered based on weight at 10 mg/kg IV every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle, or will be administered at a fixed dose of 1500 mg IV every 4 weeks (Q4W) (for participants whose weight >/= 30 kg) on Day 1 of each 28-day cycle. |
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PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS. |
| From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
| Confirmed Objective Response Rate (ORR), as Assessed by an IRF in PPAS | ORR was defined as the percentage of participants who achieved an objective response (OR), characterized by a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesion & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | Up to approximately 57 months |
| Confirmed ORR, as Assessed by the Investigator in PPAS | ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | Up to approximately 57 months |
| Duration of Response (DOR), as Assessed by an IRF in PPAS | DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method. | From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
| DOR, as Assessed by the Investigator in PPAS | DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method. | From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
| Time to Confirmed Deterioration (TTCD) in Cough, as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) in PPAS | TTCD=time from randomization until first confirmed clinically meaningful deterioration (CCMD) on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Cough scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in PPAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| TTCD in Global Health Status (GHS)/Quality-of-life (QoL), as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Core-30 (EORTC QLQ-C30) in PPAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a score range of 0-100. High score for GHS/QoL scale=better health-related quality-of-life (HRQoL). CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments/initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a score range of 0-100. High score for PF=high/healthy level of functioning. CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| OS in FAS | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. | From randomization to death from any cause (up to approximately 57 months) |
| PFS, as Assessed by the Investigator in FAS | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS. | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
| Confirmed ORR, as Assessed by an IRF in FAS | ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | Up to approximately 57 months |
| Confirmed ORR, as Assessed by the Investigator in FAS | ORR was defined as the percentage of participants who achieved an OR, characterized by a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | Up to approximately 57 months |
| DOR, as Assessed by an IRF in FAS | DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method. | From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
| DOR, as Assessed by the Investigator in FAS | DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method. | From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
| TTCD in Cough, as Assessed Using EORTC QLQ-LC13 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Cough was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| TTCD in GHS/QoL, as Assessed Using EORTC QLQ-C30 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a score range of 0-100. High score for GHS/QoL scale=better HRQoL. CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| TTCD in PF, as Assessed Using EORTC QLQ-C30 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a score range of 0-100. High score for PF=high/healthy level of functioning. CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD. | Up to approximately 57 months |
| PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in PPAS | PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS rate. Percentages have been rounded off. | At Months 12, 18, and 24 |
| PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS | PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS rate. Percentages have been rounded off. | At Months 12, 18, and 24 |
| OS Rate at 12, 24, 36, and 48 Months in PPAS | OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off. | At Months 12, 24, 36, and 48 |
| Time-to-distant Metastasis (TTDM), as Assessed by the Investigator in PPAS | TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first. Distant metastasis was defined as any new lesion that was outside of the radiation field. K-M method was used to estimate median TTDM. | Up to approximately 57 months |
| PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in FAS | PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate PFS rate. Percentages have been rounded off. | At Months 12, 18, and 24 |
| PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in FAS | PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate PFS rate. Percentages have been rounded off. | At Months 12, 18, and 24 |
| OS Rate at 12, 24, 36, and 48 Months in FAS | OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off. | At Months 12, 24, 36, and 48 |
| TTDM, as Assessed by the Investigator in FAS | TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first. Distant metastasis was defined as any new lesion that was outside of the radiation field. K-M method was used to estimate median TTDM. | Up to approximately 57 months |
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. | Up to approximately 24.7 months |
| Number of Participants With Cytokine Release Syndrome (CRS) | CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. | Up to approximately 24.7 months |
| Greeley |
| Colorado |
| 80631 |
| United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33901-8101 | United States |
| Cancer Care Centers of Brevard | Palm Bay | Florida | 32901 | United States |
| Woodlands Medical Specialists, P.A. | Pensacola | Florida | 32503 | United States |
| Florida Cancer Specialist, North Region | St. Petersburg | Florida | 33705 | United States |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| New England Cancer Specialists | Brunswick | Maine | 04011 | United States |
| Southcoast Health System | Fairhaven | Massachusetts | 02719 | United States |
| Minnesota Oncology Hematology | Minneapolis | Minnesota | 55404 | United States |
| HCA Midwest Health | Kansas City | Missouri | 64132 | United States |
| Cox Health Systems | Springfield | Missouri | 65807 | United States |
| Optum Health Care | Las Vegas | Nevada | 89106 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | United States |
| Titan Health Partners LLC, d/b/a Astera Cancer Care | East Brunswick | New Jersey | 08816 | United States |
| San Juan Oncology Associates | Farmington | New Mexico | 87401 | United States |
| New York Oncology Hematology,P.C.-Albany | Albany | New York | 12208 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Prisma Health ? Upstate | Greenville | South Carolina | 29615 | United States |
| Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37403 | United States |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| CEMIC | Buenos Aires | C1431FWO | Argentina |
| Hospital Britanico de Buenos Aires | Ciudad Autonoma Buenos Aires | C1284AEB | Argentina |
| Clinica Universitaria Reina Fabiola | Córdoba | X5004FHP | Argentina |
| Sanatorio Parque S.A. | Rosario | S2000QGB | Argentina |
| Blacktown Hospital | Blacktown | New South Wales | 2148 | Australia |
| Macarthur Cancer Therapy Centre | Campbelltown | New South Wales | 2560 | Australia |
| St George Hospital | Kogarah | New South Wales | 2217 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Monash Health Translational Precinct | Victoria | Victoria | 3168 | Australia |
| Fiona Stanley Hospital | Bull Creek | Western Australia | 6149 | Australia |
| Tiroler Landeskrankenanstalten Ges.M.B.H. | Innsbruck | 6020 | Austria |
| Kepler Universitätskliniken GmbH - Med Campus III | Linz | 4020 | Austria |
| Klinik Penzing | Vienna | 1140 | Austria |
| GHdC Site Les Viviers | Charleroi | 6000 | Belgium |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| Jessa Zkh (Campus Virga Jesse) | Hasselt | 3500 | Belgium |
| Crio - Centro Regional Integrado de Oncologia | Fortaleza | Ceará | 60336-550 | Brazil |
| Centro Integrado de Oncologia de Curitiba | Curitiba | Paraná | 80810-050 | Brazil |
| Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Hospital de Base de Sao Jose do Rio Preto | São José do Rio Preto | São Paulo | 15090-000 | Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| BC Cancer ? Abbotsford | Abbotsford British Columbia | British Columbia | V2S 0C2 | Canada |
| BC Cancer - Victoria | Victoria | British Columbia | V8R 6V5 | Canada |
| Royal Victoria Regional Health Centre | Barrie | Ontario | L4M 6M2 | Canada |
| William Osler Health System Brampton Civic Hospital | Brampton | Ontario | L6R 3J7 | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Beijing Cancer Center | Beijing | 100142 | China |
| Beijing Chest Hospital | Beijing | 101149 | China |
| Jilin Cancer Hospital | Changchun | 132013 | China |
| Xiangya Hospital Central South University | Changsha | 410008 | China |
| Sichuan Provincial Cancer Hospital | Chengdu | 610041 | China |
| Chongqing Cancer Hospital | Chongqing | 400030 | China |
| Fujian Medical University Union Hospital | Fujian | 350001 | China |
| Fujian Provincial Cancer Hospital | Fuzhou | 350014 | China |
| Cancer Center, Sun Yat-sen University of Medical Sciences | Guangzhou | 510060 | China |
| Hangzhou Cancer Hospital | Hangzhou | 310002 | China |
| Shandong Cancer Hospital | Jinan | 250117 | China |
| Zhongda Hospital Affiliated to Southeast University | Nanjing | 210009 | China |
| The affiliated hospital of Qingdao university | Qingdao | 266042 | China |
| Shanghai Chest Hospital | Shanghai | 200000 | China |
| Cancer Hospital of Shantou University Medical College | Shantou | 515041 | China |
| Shanxi Provincial Cancer Hospital | Taiyuan | 030013 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| The 2nd School of Medicine, WMU | Wenzhou | 325000 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | 361003 | China |
| The Affiliated Hospital of Xuzhou Medical College | Xuzhou | 221000 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| CHU Angers | Angers | 49933 | France |
| Centre Francois Baclesse | Caen | 14000 | France |
| Hopital Nord AP-HM | Marseille | 13015 | France |
| Clinique Clémentville | Montpellier | 34070 | France |
| Hopital Robert Schuman | Vantoux | 57070 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Klinikum Braunschweig | Braunschweig | 38114 | Germany |
| Klinikum Koeln-Merheim | Cologne | 51109 | Germany |
| Universitaetsmedizin Goettingen | Göttingen | 37075 | Germany |
| Thoraxklinik Heidelberg gGmbH | Heidelberg | 69126 | Germany |
| Klinikum Bogenhausen | München | 81925 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| General Hospital "G.Papanikolaou" | Asvestochóri | 570 10 | Greece |
| Sotiria Hospital | Athens | 11527 | Greece |
| Agioi Anargyroi Cancer Hospital | Kifissia | 145 64 | Greece |
| Princess Margaret Hospital, Oncology | Hong Kong | DUMMY_VALUE | Hong Kong |
| Queen Elizabeth Hospital | Hong Kong | DUMMY_VALUE | Hong Kong |
| Pamela Youde Nethersole Eastern Hospital | Hong Kong | Hong Kong |
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| Queen Mary Hospital | Pokfulam | DUMMY_VALUE | Hong Kong |
| Pécsi Tudományegyetem | Pécs | 7623 | Hungary |
| Szent Borbala Korhaz | Tatabánya | 2800 | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | 2045 | Hungary |
| Soroka Medical Center | Beersheba | 8410100 | Israel |
| Rambam Medical Center | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Rabin Medical Center | Petah Tikva | 4941492 | Israel |
| Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale | Naples | Campania | 80131 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola | Meldola | Emilia-Romagna | 47014 | Italy |
| Azienda Ospedaliero Universitaria di Parma | Parma | Emilia-Romagna | 43100 | Italy |
| Policlinico Universitario Campus Biomedico | Rome | Lazio | 00128 | Italy |
| IRCCS Istituto Regina Elena (IFO) | Rome | Lazio | 00144 | Italy |
| IRCCS AOU San Martino - IST | Genoa | Liguria | 16132 | Italy |
| A.O. Spedali Civili Di Brescia-P.O. Spedali Civili | Brescia | Lombardy | 25123 | Italy |
| Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda) | Milan | Lombardy | DUMMY_VALUE | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Lombardy | 27100 | Italy |
| Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello | Pisa | Tuscany | 56124 | Italy |
| Azienda ULSS 8 Berica | Vicenza | Veneto | 36100 | Italy |
| Aichi Cancer Center | Aichi | 464-8681 | Japan |
| National Cancer Center East | Chiba | 277-8577 | Japan |
| National Hospital Organization Himeji Medical Center | Hyōgo | 670-8520 | Japan |
| Kitasato University Hospital | Kanagawa | 252-0375 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Sendai Kousei Hospital | Miyagi | 981-0914 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Kindai University Hospital | Osaka | 589-8511 | Japan |
| Saitama Cancer Center | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641-8510 | Japan |
| Meander Medisch Centrum | Amersfoort | 3813 TZ | Netherlands |
| Amphia Ziekenhuis | Breda | 4819 EV | Netherlands |
| Medisch Centrum Haaglanden, locatie Antoniushove | Leidschendam | 2262 BA | Netherlands |
| Zuyderland Medisch Centrum - Sittard Geleen | Sittard-Geleen | 6162 BG | Netherlands |
| Auckland City Hospital, Cancer and Blood Research | Auckland | 1023 | New Zealand |
| Uniwersyteckie Centrum Kliniczne | Gda?sk | 80-214 | Poland |
| Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii | Olsztyn | 10-228 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy | Otwock | 05-400 | Poland |
| Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad | Warsaw | 02-781 | Poland |
| Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii | Wroc?aw | 53-413 | Poland |
| IPO de Coimbra | Coimbra | 3000-075 | Portugal |
| Hospital da Luz | Lisbon | 1500-650 | Portugal |
| Hospital CUF Porto | Porto | 4100-180 | Portugal |
| IPO do Porto | Porto | 4200-072 | Portugal |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Ajou University Medical Center | Gyeonggi-do | 16499 | South Korea |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Ulsan University Hosiptal | Ulsan | 44033 | South Korea |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Provincial de Castellon | Castellon | Castellon | 12002 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | 15006 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Univ. Nuestra Señora de Valme | Seville | 41014 | Spain |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan |
| Vajira Hospital | Bangkok | 10300 | Thailand |
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital;Medicine/Oncology | Bangkok | 10400 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Adana Baskent University Medical Faculty | Adana | 01220 | Turkey (Türkiye) |
| Ankara University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | 06100 | Turkey (Türkiye) |
| Gazi University Medical Faculty, Oncology Hospital | Ankara | 06500 | Turkey (Türkiye) |
| Ege University Medical Faculty | Bornova, ?zm?r | 35100 | Turkey (Türkiye) |
| Dicle University Faculty of Medicine | Diyarbakır | 21280 | Turkey (Türkiye) |
| Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Faculty of Medicine | Istanbul | 34098 | Turkey (Türkiye) |
| Medipol University Medical Faculty | Istanbul | 34214 | Turkey (Türkiye) |
| Inonu University Faculty of Medicine Turgut Ozal Medical Center | Malatya | 44280 | Turkey (Türkiye) |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Addenbrooke's NHS Trust | Cambridge | CB2 0QQ | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Calderdale & Huddersfield Nhs Trust | Huddersfield | HD3 3EA | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Maidstone & Tonbridge Wells Hospital | Maidstone | ME16 9QQ | United Kingdom |
| Christie Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Weston Park Hospital | Sheffield | S10 2SJ | United Kingdom |
Participants received atezolizumab, 1680 mg, IV, followed by tiragolumab, 840 mg, IV, on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
| Safety Analysis Set (SAS) | SAS included all randomized participants who received at least one dose of study treatment, with participants analyzed according to the intervention actually received. |
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| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set (FAS) included all randomized participants, regardless of whether or not the participant received the assigned treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Durvalumab | Participants received durvalumab, 10 mg/kg, IV, on Days 1 and 15 of each 28-day cycle or 1500 mg (for participants weighing ≥ 30 kg), IV on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
| BG001 | Atezolizumab + Tiragolumab | Participants received atezolizumab, 1680 mg, IV, followed by tiragolumab, 840 mg, IV, on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Secondary | Overall Survival (OS) in PPAS | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Median | 95% Confidence Interval | months | From randomization to death from any cause (up to approximately 57 months) |
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| Secondary | PFS, as Assessed by the Investigator in PPAS | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Median | 95% Confidence Interval | months | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
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| Secondary | Confirmed Objective Response Rate (ORR), as Assessed by an IRF in PPAS | ORR was defined as the percentage of participants who achieved an objective response (OR), characterized by a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesion & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. Overall number analyzed included all randomized participants with measurable disease at baseline, as determined by an IRF. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 57 months |
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| Secondary | Confirmed ORR, as Assessed by the Investigator in PPAS | ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. Overall number analyzed included all randomized participants with measurable disease at baseline, as determined by the investigator. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 57 months |
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| Secondary | Duration of Response (DOR), as Assessed by an IRF in PPAS | DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. Overall number analyzed is the number of participants with a confirmed OR. | Posted | Median | 95% Confidence Interval | months | From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
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| Secondary | DOR, as Assessed by the Investigator in PPAS | DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. Overall number analyzed is the number of participants with a confirmed OR. | Posted | Median | 95% Confidence Interval | months | From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
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| Secondary | Time to Confirmed Deterioration (TTCD) in Cough, as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) in PPAS | TTCD=time from randomization until first confirmed clinically meaningful deterioration (CCMD) on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Cough scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in PPAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in PPAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, who had not progressed after concurrent platinum-based CRT. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | TTCD in Global Health Status (GHS)/Quality-of-life (QoL), as Assessed Using European Organisation for Research and Treatment of Cancer Quality-of-life Core-30 (EORTC QLQ-C30) in PPAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a score range of 0-100. High score for GHS/QoL scale=better health-related quality-of-life (HRQoL). CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments/initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | TTCD in Physical Functioning (PF), as Assessed Using EORTC QLQ-C30 in PPAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a score range of 0-100. High score for PF=high/healthy level of functioning. CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | OS in FAS | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate median OS. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to death from any cause (up to approximately 57 months) |
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| Secondary | PFS, as Assessed by the Investigator in FAS | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
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| Secondary | Confirmed ORR, as Assessed by an IRF in FAS | ORR was defined as the percentage of participants who achieved an OR, characterized by CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by an IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. Overall number analyzed included all randomized participants with measurable disease at baseline, as determined by an IRF. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 57 months |
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| Secondary | Confirmed ORR, as Assessed by the Investigator in FAS | ORR was defined as the percentage of participants who achieved an OR, characterized by a CR or PR on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. Overall number analyzed included all randomized participants with measurable disease at baseline, as determined by the investigator. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 57 months |
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| Secondary | DOR, as Assessed by an IRF in FAS | DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. Overall number analyzed is the number of participants with a confirmed OR. | Posted | Median | 95% Confidence Interval | months | From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
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| Secondary | DOR, as Assessed by the Investigator in FAS | DOR was defined as the time from the first occurrence of a confirmed OR, characterized by CR or PR, until the first date of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Median DOR was estimated using the K-M method. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. Overall number analyzed is the number of participants with a confirmed OR. | Posted | Median | 95% Confidence Interval | months | From first occurrence of a confirmed OR until the first date of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
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| Secondary | TTCD in Cough, as Assessed Using EORTC QLQ-LC13 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Cough was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | TTCD in Dyspnoea, as Assessed Using EORTC QLQ-LC13 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Dyspnoea was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | TTCD in Chest Pain, as Assessed Using EORTC QLQ-LC13 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-LC13 is a lung cancer-specific instrument consisting of 13 questions: one multiple-item scale assessing dyspnoea (3 items), and 10 single items assessing cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication. Chest pain was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to score range of 0-100. High symptom score=high level of symptom severity. CCMD=increase from baseline (≥10 points) in a symptom score, held for at least two consecutive assessments or an initial clinically meaningful increase above baseline followed by death from any cause within 6 weeks. K-M method was used to estimate median TTCD. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | TTCD in GHS/QoL, as Assessed Using EORTC QLQ-C30 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). GHS/QoL questions were scored on 7-point scale with scores ranging from 1=Very poor to 7=Excellent. Scores were linearly transformed to a score range of 0-100. High score for GHS/QoL scale=better HRQoL. CCMD=decrease from baseline (≥10 points) in GHS/QoL scale score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | TTCD in PF, as Assessed Using EORTC QLQ-C30 in FAS | TTCD=time from randomization until first CCMD on each respective score. EORTC QLQ-C30 is cancer-specific instrument consisting of 30 questions to evaluate 5 aspects of participant functioning (physical, emotional, role, cognitive, & social), 3 symptom scales (fatigue, nausea, vomiting, & pain), GHS/QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties). PF was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a score range of 0-100. High score for PF=high/healthy level of functioning. CCMD=decrease from baseline (≥10 points) in PF score, held for at least 2 consecutive assessments or initial clinically meaningful decrease above baseline followed by death within 6 weeks. K-M method was used to estimate median TTCD. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in PPAS | PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS rate. Percentages have been rounded off. | PPAS included all participants in the FAS with locally advanced, PD-L1 positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 12, 18, and 24 |
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| Secondary | PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in PPAS | PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS rate. Percentages have been rounded off. | PPAS included all participants in the FAS with locally advanced, PD-L1 positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 12, 18, and 24 |
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| Secondary | OS Rate at 12, 24, 36, and 48 Months in PPAS | OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 12, 24, 36, and 48 |
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| Secondary | Time-to-distant Metastasis (TTDM), as Assessed by the Investigator in PPAS | TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first. Distant metastasis was defined as any new lesion that was outside of the radiation field. K-M method was used to estimate median TTDM. | PPAS included all participants in the FAS with locally advanced, PD-L1-positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | PFS Rate at 12, 18, and 24 Months, as Assessed by an IRF in FAS | PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by an IRF, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate PFS rate. Percentages have been rounded off. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 12, 18, and 24 |
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| Secondary | PFS Rate at 12, 18, and 24 Months, as Assessed by the Investigator in FAS | PFS rate at 12, 18, and 24 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at 12, 18, and 24 months. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate PFS rate. Percentages have been rounded off. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 12, 18, and 24 |
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| Secondary | OS Rate at 12, 24, 36, and 48 Months in FAS | OS rate at months 12, 24, 36 and 48 was defined as percentage of participants who did not experience death from any cause at the specified timepoints. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 12, 24, 36, and 48 |
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| Secondary | TTDM, as Assessed by the Investigator in FAS | TTDM was defined as the time from the date of randomization until the date of first documented distant metastasis, as assessed by investigator according to RECIST v1.1, or death, whichever occurred first. Distant metastasis was defined as any new lesion that was outside of the radiation field. K-M method was used to estimate median TTDM. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 57 months |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product. | SAS included all randomized participants who received at least one dose of study treatment, with participants analyzed according to the intervention actually received. | Posted | Count of Participants | Participants | Up to approximately 24.7 months |
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| Secondary | Number of Participants With Cytokine Release Syndrome (CRS) | CRS=supraphysiologic response following administration of any immune therapy that results in activation/engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms may be progressive, including fever at onset, and may also include hypotension, capillary leak (hypoxia), and end-organ dysfunction. | SAS included all randomized participants who received at least one dose of study treatment, with participants analyzed according to the intervention actually received. | Posted | Count of Participants | Participants | Up to approximately 24.7 months |
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| Primary | Progression-free Survival (PFS), as Assessed by an Independent Review Facility (IRF) in Programmed Death-ligand 1 (PD-L1) Positive Analysis Set (PPAS) | PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 millimeters (mm) or unequivocal progression of existing non-target lesions. Kaplan-Meier (K-M) method was used to estimate median PFS. | PPAS included all participants in the FAS with locally advanced, PD-L1 positive, unresectable Stage III NSCLC, who had not progressed after concurrent platinum-based CRT. | Posted | Median | 95% Confidence Interval | months | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
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| Primary | PFS, as Assessed by an IRF in FAS | PFS was defined as the time from randomization to the first occurrence of PD, as determined by an IRF according to RECIST v1.1, or death from any cause, whichever occurred 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate median PFS. | FAS included all randomized participants, regardless of whether or not the participant received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 57 months) |
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All-cause mortality: Up to approximately 57 months Serious and other AEs: Up to approximately 24.7 months
SAEs & other AEs: SAS= all randomized participants who received at least one dose of study treatment, with participants analyzed according to the intervention actually received. All-cause mortality: FAS=all randomized participants, regardless of whether or not the participant received the assigned treatment.
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 | Durvalumab | Participants received durvalumab, 10 mg/kg, IV, on Days 1 and 15 of each 28-day cycle or 1500 mg (for participants weighing ≥ 30 kg), IV on Day 1 of each 28-day cycle for a maximum of 13 cycles. | 191 | 416 | 133 | 413 | 355 | 413 |
| EG001 | Atezolizumab + Tiragolumab | Participants received atezolizumab, 1680 mg, IV, followed by tiragolumab, 840 mg, IV, on Day 1 of each 28-day cycle for a maximum of 13 cycles. | 186 | 413 | 134 | 407 | 355 | 407 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 28.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Atrioventricular block second degree | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA version 28.0 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA version 28.0 | Systematic Assessment |
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| Hypophysitis | Endocrine disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Autoimmune pancreatitis | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Femoral hernia incarcerated | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Oesophageal fistula | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Oesophageal stenosis | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 28.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 28.0 | Systematic Assessment |
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| Polyp | General disorders | MedDRA version 28.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Coronavirus pneumonia | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
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| Enteritis infectious | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
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| Pulmonary tuberculosis | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
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| Staphylococcal infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Vascular device infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
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| Compression fracture | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
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| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
| |
| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Influenza A virus test positive | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.0 | Systematic Assessment |
| |
| Sinonasal papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.0 | Systematic Assessment |
| |
| Small intestine adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Haemorrhagic transformation stroke | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Immune-mediated myelitis | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 28.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2024 | Mar 25, 2026 | 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 |
| C000730814 | Tiragolumab |
| C000613593 | durvalumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
| OG001 | Atezolizumab + Tiragolumab | Participants received atezolizumab, 1680 mg, IV, followed by tiragolumab, 840 mg, IV, on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
|
|
| OG001 |
| Atezolizumab + Tiragolumab |
Participants received atezolizumab, 1680 mg, IV, followed by tiragolumab, 840 mg, IV, on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
|
|
| Atezolizumab + Tiragolumab |
Participants received atezolizumab, 1680 mg, IV, followed by tiragolumab, 840 mg, IV, on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
|
|
|
|
|
|
|
|
|
Participants received atezolizumab, 1680 mg, IV, followed by tiragolumab, 840 mg, IV, on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Atezolizumab + Tiragolumab |
Participants received atezolizumab, 1680 mg, IV, followed by tiragolumab, 840 mg, IV, on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
|
|
| Atezolizumab + Tiragolumab |
Participants received atezolizumab, 1680 mg, IV, followed by tiragolumab, 840 mg, IV, on Day 1 of each 28-day cycle for a maximum of 13 cycles. |
|
|
|
|
|
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| Units | Counts |
|---|
| Participants |
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