A Phase 2/3 interventional study of Tiragolumab and Atezolizumab in Non-small Cell Lung Cancer (NSCLC), sponsored by Hoffmann-La Roche. Completed at 127 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Hoffmann-La Roche · Phase 2/3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).
Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase:
Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 542 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle.
Drug: Tiragolumab · Drug: Atezolizumab · Drug: Pemetrexed · Drug: Carboplatin · Drug: Cisplatin
Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle.
Drug: Pemetrexed · Drug: Carboplatin · Drug: Cisplatin · Drug: Tiragolumab Matching Placebo · Drug: Pembrolizumab
Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Also known as: MTIG7192A
Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Also known as: Tecentriq
Pemetrexed 500 milligrams per square meter (mg/m\^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Carboplatin at dose of area under the concentration-time curve (AUC) of 5, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Cisplatin 75 mg/m\^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle.
Progression-free Survival (PFS) as Determined by the Investigator
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. Kaplan-Meier (KM) methodology was used to estimate the median PFS.
Time frame: From randomization to first occurrence of PD or death from any cause (up to approximately 40 months)
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.
Time frame: From randomization to death from any cause (up to approximately 40 months)
PFS as Determined by the Independent Review Facility (IRF)
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS.
Time frame: From randomization to first occurrence of PD or death from any cause (up to approximately 40 months)
Investigator Assessed PFS in Participants With PD-L1 Expression at TPS/TC >=1%
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS.
Time frame: From randomization to first occurrence of PD or death from any cause (up to approximately 40 months)
Investigator Assessed PFS in Participants With PD-L1 Expression at TPS/TC >=50%
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS.
Time frame: From randomization to first occurrence of PD or death from any cause (up to approximately 40 months)
OS in Participants With PD-L1 Expression at TPS/TC >=1%
OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.
Time frame: From randomization to death from any cause (up to approximately 40 months)
OS in Participants With PD-L1 Expression at TPS/TC >= 50%
OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.
Time frame: From randomization to death from any cause (up to approximately 40 months)
PFS Rate at Month 6 and Month 12
PFS at 6 months and 12 months was defined as the percentage of participants who have not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 months and at 12 months, respectively. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions.
Time frame: At Month 6 and Month 12
OS Rate at Month 12 and Month 24
OS rate at 12 months and 24 months was defined as the percentage of participants who have not experienced death from any cause at 12 and 24 months, respectively.
Time frame: At Month 12 and Month 24
Duration of Response (DOR)
DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. Complete response (CR) was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \<10 millimeters (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. Partial response (PR) 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) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. KM methodology was used to estimate the median DOR.
Time frame: Up to approximately 40 months
Objective Response Rate (ORR)
ORR was defined as a percentage of participants with 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. Any pathological lymph nodes (whether target or non-target lesions) 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.
Time frame: Up to approximately 40 months
Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning (PF) as Measured by European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC-QLQ-C30)
EORTC QLQ-C30=self-reported measure, with 30 questions assessing 5 aspects of subjects functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting, \& pain), global health status (GHS) \& Quality of Life (QoL), \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties) within the previous week. Functioning \& symptoms items were scored on a 4-point scale: 1=not at all to 4=very much. Scores were linearly transformed to a range of 0 to 100, with higher scores reflecting better functioning. TTCD was defined time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration was defined as score decrease of ≥10 from baseline in PF scale score that were held for at least two consecutive assessments or an initial ≥10 decrease from baseline followed by death from any cause within 3 weeks.
Time frame: Up to approximately 40 months
TTCD in Participant-Reported Global Health Status (GHS)/Quality of Life (QoL) as Measured by EORTC QLQ-C30
EORTC QLQ-C30=self-reported measure, with 30 questions assessing 5 aspects of subjects functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting, \& pain), global health status (GHS) \& Quality of Life (QoL), \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties) within the previous week . GHS and QoL items were scored on a 7-point scale (1=very poor 7=excellent). Scores were linearly transformed to a range of 0 to 100, with higher scores reflecting better GHS/QoL. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration was defined as score decrease of ≥10 from baseline in GHS/QoL scale score that were held for at least two consecutive assessments or an initial ≥10 decrease from baseline followed by death from any cause within 3 weeks.
Time frame: Up to approximately 40 months
TTCD in Participant-Reported Dyspnoea as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)
The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Symptoms were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of dyspnoea. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks.
Time frame: Up to approximately 40 months
TTCD in Participant-Reported Chest Pain, as Measured by EORTC QLQ-LC13
The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Chest pain were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of chest pain. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks.
Time frame: Up to approximately 40 months
TTCD in Participant-Reported Cough, as Measured by EORTC QLQ-LC13
The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Cough were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of cough. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks.
Time frame: Up to approximately 40 months
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Time frame: From study start up to 90 days after last dose (up to approximately 40.8 months)
Number of Participants With Response to Side Effects of Treatment as Assessed by European Organisation for Research and Treatment of Cancer Item List 46 (EORTC IL46)
The EORTC IL46 is a validated single-item question that assesses overall side effect impact, i.e. "To what extent have you been troubled with side-effects from your treatment ". Each item is scored on a 4-point scale (1= Not at all, 2= A Little, 3= Quite a Bit, and 4= Very Much).
Time frame: Baseline, Day 1 of Cycles 2, 3, 4, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57 and treatment discontinuation visit (each cycle=21 days) (Up to 40 months)
Serum Concentration of Atezolizumab
Time frame: Predose Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 and at treatment completion (TC)/early discontinuation (ED); and 0.5 hour (h) postdose Day 1 of Cycle 1 (each cycle=21 days) (Up to 40 months)
Serum Concentration of Tiragolumab
Time frame: Predose Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 and at TC/ED; and 0.5 hour (h) postdose Day 1 of Cycle 1 (each cycle=21 days) (Up to 40 months)
Number of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Atezolizumab
Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
Time frame: Up to approximately 40 months
Number of Participants With Treatment-Emergent ADAs to Tiragolumab
Participants who received tiragolumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
Time frame: Up to approximately 40 months
A total of 542 participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) took part in the study at 129 investigative sites across 21 countries from 15 December 2020 to 20 November 2025.
| Milestone | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Started | 273 | 269 |
| Safety-evaluable set | 272 | 267 |
| Completed | 0 | 0 |
| Not completed | 273 | 269 |
| Withdrew: Withdrawal by subject | 20 | 15 |
| Withdrew: Study ended by sponsor | 137 | 108 |
| Withdrew: Protocol deviation | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Death | 113 | 145 |
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. Kaplan-Meier (KM) methodology was used to estimate the median PFS.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Progression-free Survival (PFS) as Determined by the Investigator | 9.89 (8.71 to 11.89) | 8.31 (7.13 to 9.59) |
OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Overall Survival (OS) | 23.10 (20.73 to 32.95) | 18.89 (15.24 to 23.79) |
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS.
No measurements were reported for this outcome.
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Investigator Assessed PFS in Participants With PD-L1 Expression at TPS/TC >=1% | 11.96 (9.72 to 16.59) | 9.82 (8.25 to 12.85) |
PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Investigator Assessed PFS in Participants With PD-L1 Expression at TPS/TC >=50% | 14.09 (10.94 to 33.74) | 11.76 (9.46 to 15.21) |
OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| OS in Participants With PD-L1 Expression at TPS/TC >=1% | 33.58 (22.64 to NA) | 20.70 (16.89 to 32.92) |
OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| OS in Participants With PD-L1 Expression at TPS/TC >= 50% | 33.58 (22.64 to NA) | 23.79 (17.28 to NA) |
PFS at 6 months and 12 months was defined as the percentage of participants who have not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 months and at 12 months, respectively. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions.
| percentage of participants | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Month 6 | 68.52 (62.94 to 74.10) | 61.12 (55.25 to 66.99) |
| Month 12 | 42.79 (36.42 to 49.15) | 34.26 (28.21 to 40.31) |
OS rate at 12 months and 24 months was defined as the percentage of participants who have not experienced death from any cause at 12 and 24 months, respectively.
| percentage of participants | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Month 12 | 72.34 (66.76 to 77.92) | 63.38 (57.34 to 69.43) |
| Month 24 | 47.95 (39.14 to 56.77) | 41.90 (33.98 to 49.82) |
DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. Complete response (CR) was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \<10 millimeters (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. Partial response (PR) 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) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. KM methodology was used to estimate the median DOR.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Duration of Response (DOR) | 11.1 (9.5 to 18.9) | 9.4 (8.2 to 11.7) |
ORR was defined as a percentage of participants with 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. Any pathological lymph nodes (whether target or non-target lesions) 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.
| percentage of participants | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Objective Response Rate (ORR) | 56.6 (50.49 to 62.55) | 50.2 (44.07 to 56.30) |
EORTC QLQ-C30=self-reported measure, with 30 questions assessing 5 aspects of subjects functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting, \& pain), global health status (GHS) \& Quality of Life (QoL), \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties) within the previous week. Functioning \& symptoms items were scored on a 4-point scale: 1=not at all to 4=very much. Scores were linearly transformed to a range of 0 to 100, with higher scores reflecting better functioning. TTCD was defined time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration was defined as score decrease of ≥10 from baseline in PF scale score that were held for at least two consecutive assessments or an initial ≥10 decrease from baseline followed by death from any cause within 3 weeks.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning (PF) as Measured by European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC-QLQ-C30) | 30.36 (25.33 to NA) | 20.76 (11.79 to NA) |
EORTC QLQ-C30=self-reported measure, with 30 questions assessing 5 aspects of subjects functioning (physical, emotional, role, cognitive \& social), 3 symptom scales (fatigue, nausea \& vomiting, \& pain), global health status (GHS) \& Quality of Life (QoL), \& 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea \& financial difficulties) within the previous week . GHS and QoL items were scored on a 7-point scale (1=very poor 7=excellent). Scores were linearly transformed to a range of 0 to 100, with higher scores reflecting better GHS/QoL. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration was defined as score decrease of ≥10 from baseline in GHS/QoL scale score that were held for at least two consecutive assessments or an initial ≥10 decrease from baseline followed by death from any cause within 3 weeks.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| TTCD in Participant-Reported Global Health Status (GHS)/Quality of Life (QoL) as Measured by EORTC QLQ-C30 | NA (14.55 to NA) | NA (17.05 to NA) |
The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Symptoms were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of dyspnoea. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| TTCD in Participant-Reported Dyspnoea as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) | 16.99 (10.32 to NA) | 23.52 (11.73 to NA) |
The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Chest pain were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of chest pain. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| TTCD in Participant-Reported Chest Pain, as Measured by EORTC QLQ-LC13 | NA (NA to NA) | NA (NA to NA) |
The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Cough were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of cough. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks.
| months | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| TTCD in Participant-Reported Cough, as Measured by EORTC QLQ-LC13 | NA (NA to NA) | NA (NA to NA) |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
| Participants | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 267 | 262 |
The EORTC IL46 is a validated single-item question that assesses overall side effect impact, i.e. "To what extent have you been troubled with side-effects from your treatment ". Each item is scored on a 4-point scale (1= Not at all, 2= A Little, 3= Quite a Bit, and 4= Very Much).
| Participants | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| Baseline — Not at all | 207 | 192 |
| Baseline — A Little | 33 | 44 |
| Baseline — Quite a bit | 8 | 12 |
| Baseline — Very Much | 8 | 3 |
| Cycle 2 Day 1 — Not at all | 100 | 73 |
| Cycle 2 Day 1 — A Little | 112 | 125 |
| Cycle 2 Day 1 — Quite a bit | 32 | 41 |
| Cycle 2 Day 1 — Very Much | 14 | 9 |
| Cycle 3 Day 1 — Not at all | 89 | 70 |
| Cycle 3 Day 1 — A Little | 113 | 112 |
| Cycle 3 Day 1 — Quite a bit | 32 | 40 |
| Cycle 3 Day 1 — Very Much | 8 | 11 |
| Cycle 4 Day 1 — Not at all | 86 | 64 |
| Cycle 4 Day 1 — A Little | 113 | 107 |
| Cycle 4 Day 1 — Quite a bit | 30 | 37 |
| Cycle 4 Day 1 — Very Much | 10 | 8 |
| Cycle 5 Day 1 — Not at all | 86 | 65 |
| Cycle 5 Day 1 — A Little | 94 | 104 |
| Cycle 5 Day 1 — Quite a bit | 34 | 34 |
| Cycle 5 Day 1 — Very Much | 11 | 5 |
| Cycle 7 Day 1 — Not at all | 81 | 59 |
| Cycle 7 Day 1 — A Little | 82 | 84 |
| Cycle 7 Day 1 — Quite a bit | 23 | 29 |
| Cycle 7 Day 1 — Very Much | 8 | 7 |
| Cycle 9 Day 1 — Not at all | 70 | 49 |
| Cycle 9 Day 1 — A Little | 73 | 73 |
| Cycle 9 Day 1 — Quite a bit | 24 | 25 |
| Cycle 9 Day 1 — Very Much | 3 | 5 |
| Cycle 11 Day 1 — Not at all | 61 | 41 |
| Cycle 11 Day 1 — A Little | 68 | 69 |
| Cycle 11 Day 1 — Quite a bit | 14 | 16 |
| Cycle 11 Day 1 — Very Much | 1 | 7 |
| Cycle 13 Day 1 — Not at all | 57 | 44 |
| Cycle 13 Day 1 — A Little | 56 | 40 |
| Cycle 13 Day 1 — Quite a bit | 12 | 17 |
| Cycle 13 Day 1 — Very Much | 2 | 10 |
| Cycle 15 Day 1 — Not at all | 47 | 33 |
| Cycle 15 Day 1 — A Little | 42 | 46 |
| Cycle 15 Day 1 — Quite a bit | 13 | 16 |
| Cycle 15 Day 1 — Very Much | 1 | 3 |
| Cycle 17 Day 1 — Not at all | 42 | 28 |
| Cycle 17 Day 1 — A Little | 42 | 30 |
| Cycle 17 Day 1 — Quite a bit | 4 | 17 |
| Cycle 17 Day 1 — Very Much | 1 | 2 |
| Cycle 19 Day 1 — Not at all | 41 | 23 |
| Cycle 19 Day 1 — A Little | 31 | 29 |
| Cycle 19 Day 1 — Quite a bit | 7 | 6 |
| Cycle 19 Day 1 — Very Much | 1 | 2 |
| Cycle 21 Day 1 — Not at all | 25 | 18 |
| Cycle 21 Day 1 — A Little | 33 | 16 |
| Cycle 21 Day 1 — Quite a bit | 6 | 10 |
| Cycle 21 Day 1 — Very Much | 1 | 0 |
| Cycle 23 Day 1 — Not at all | 19 | 14 |
| Cycle 23 Day 1 — A Little | 26 | 17 |
| Cycle 23 Day 1 — Quite a bit | 2 | 3 |
| Cycle 23 Day 1 — Very Much | 1 | 1 |
| Cycle 25 Day 1 — Not at all | 14 | 12 |
| Cycle 25 Day 1 — A Little | 14 | 15 |
| Cycle 25 Day 1 — Quite a bit | 5 | 2 |
| Cycle 25 Day 1 — Very Much | 0 | 1 |
| Cycle 27 Day 1 — Not at all | 8 | 12 |
| Cycle 27 Day 1 — A Little | 8 | 11 |
| Cycle 27 Day 1 — Quite a bit | 4 | 2 |
| Cycle 27 Day 1 — Very Much | 1 | 1 |
| Cycle 29 Day 1 — Not at all | 7 | 8 |
| Cycle 29 Day 1 — A Little | 6 | 11 |
| Cycle 29 Day 1 — Quite a bit | 4 | 2 |
| Cycle 29 Day 1 — Very Much | 0 | 1 |
| Cycle 31 Day 1 — Not at all | 6 | 8 |
| Cycle 31 Day 1 — A Little | 4 | 7 |
| Cycle 31 Day 1 — Quite a bit | 1 | 4 |
| Cycle 31 Day 1 — Very Much | 0 | 0 |
| Cycle 33 Day 1 — Not at all | 5 | 6 |
| Cycle 33 Day 1 — A Little | 5 | 12 |
| Cycle 33 Day 1 — Quite a bit | 1 | 1 |
| Cycle 33 Day 1 — Very Much | 0 | 0 |
| Cycle 35 Day 1 — Not at all | 4 | 4 |
| Cycle 35 Day 1 — A Little | 4 | 9 |
| Cycle 35 Day 1 — Quite a bit | 0 | 1 |
| Cycle 35 Day 1 — Very Much | 0 | 0 |
| Cycle 37 Day 1 — Not at all | 5 | 3 |
| Cycle 37 Day 1 — A Little | 3 | 8 |
| Cycle 37 Day 1 — Quite a bit | 1 | 1 |
| Cycle 37 Day 1 — Very Much | 0 | 0 |
| Cycle 39 Day 1 — Not at all | 5 | 2 |
| Cycle 39 Day 1 — A Little | 5 | 9 |
| Cycle 39 Day 1 — Quite a bit | 1 | 0 |
| Cycle 39 Day 1 — Very Much | 0 | 0 |
| Cycle 41 Day 1 — Not at all | 4 | 1 |
| Cycle 41 Day 1 — A Little | 3 | 9 |
| Cycle 41 Day 1 — Quite a bit | 1 | 1 |
| Cycle 41 Day 1 — Very Much | 0 | 0 |
| Cycle 43 Day 1 — Not at all | 5 | 4 |
| Cycle 43 Day 1 — A Little | 4 | 6 |
| Cycle 43 Day 1 — Quite a bit | 0 | 1 |
| Cycle 43 Day 1 — Very Much | 0 | 0 |
| Cycle 45 Day 1 — Not at all | 4 | 4 |
| Cycle 45 Day 1 — A Little | 2 | 5 |
| Cycle 45 Day 1 — Quite a bit | 1 | 2 |
| Cycle 45 Day 1 — Very Much | 0 | 0 |
| Cycle 47 Day 1 — Not at all | 3 | 2 |
| Cycle 47 Day 1 — A Little | 2 | 8 |
| Cycle 47 Day 1 — Quite a bit | 1 | 0 |
| Cycle 47 Day 1 — Very Much | 0 | 0 |
| Cycle 49 Day 1 — Not at all | 4 | 3 |
| Cycle 49 Day 1 — A Little | 0 | 5 |
| Cycle 49 Day 1 — Quite a bit | 1 | 1 |
| Cycle 49 Day 1 — Very Much | 0 | 0 |
| Cycle 51 Day 1 — Not at all | 2 | 2 |
| Cycle 51 Day 1 — A Little | 2 | 2 |
| Cycle 51 Day 1 — Quite a bit | 0 | 1 |
| Cycle 51 Day 1 — Very Much | 0 | 0 |
| Cycle 53 Day 1 — Not at all | 2 | 3 |
| Cycle 53 Day 1 — A Little | 2 | 1 |
| Cycle 53 Day 1 — Quite a bit | 0 | 0 |
| Cycle 53 Day 1 — Very Much | 0 | 0 |
| Cycle 55 Day 1 — Not at all | 0 | 2 |
| Cycle 55 Day 1 — A Little | 2 | 1 |
| Cycle 55 Day 1 — Quite a bit | 0 | 0 |
| Cycle 55 Day 1 — Very Much | 0 | 0 |
| Cycle 57 Day 1 — Not at all | 0 | 2 |
| Cycle 57 Day 1 — A Little | 0 | 0 |
| Cycle 57 Day 1 — Quite a bit | 0 | 0 |
| Cycle 57 Day 1 — Very Much | 0 | 0 |
| Treatment Discontinuation Visit — Not at all | 58 | 35 |
| Treatment Discontinuation Visit — A Little | 50 | 61 |
| Treatment Discontinuation Visit — Quite a bit | 29 | 37 |
| Treatment Discontinuation Visit — Very Much | 15 | 12 |
| micrograms per milliliter (μg/mL) | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|
| Predose: Cycle 1 Day 1 | NA ± NA |
| Postdose: Cycle 1 Day 1 | 326 ± 278.4 |
| Predose: Cycle 2 Day 1 | 67.3 ± 128.4 |
| Predose: Cycle 3 Day 1 | 106 ± 81.9 |
| Predose: Cycle 4 Day 1 | 143 ± 52.7 |
| Predose: Cycle 8 Day 1 | 173 ± 122.1 |
| Predose: Cycle 12 Day 1 | 192 ± 66.1 |
| Predose: Cycle 16 Day 1 | 149 ± 299.6 |
| TC/ED | 97.5 ± 386.1 |
| μg/mL | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|
| Predose: Cycle 1 Day 1 | NA ± NA |
| Postdose: Cycle 1 Day 1 | 137 ± 1107.3 |
| Predose: Cycle 2 Day 1 | 32.2 ± 115.7 |
| Predose: Cycle 3 Day 1 | 51.2 ± 64.5 |
| Predose: Cycle 4 Day 1 | 69.2 ± 53.4 |
| Predose: Cycle 8 Day 1 | 79.6 ± 101.1 |
| Predose: Cycle 12 Day 1 | 89.2 ± 91.9 |
| Predose: Cycle 16 Day 1 | 67.3 ± 366.0 |
| TC/ED | 45.3 ± 331.6 |
Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
| Participants | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|
| Number of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Atezolizumab | 90 |
Participants who received tiragolumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.
| Participants | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|
| Number of Participants With Treatment-Emergent ADAs to Tiragolumab | 2 |
Collected over All AEs: From study start up to 90 days after last dose (up to approximately 40.8 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo + Pembrolizumab + Chemotherapy | 117/273 (42.9%) | 142/272 (52.2%) | 262/272 (96.3%) |
| Tiragolumab + Atezolizumab + Chemotherapy | 146/269 (54.3%) | 147/267 (55.1%) | 251/267 (94%) |
| Event | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| PneumoniaInfections and infestations | 17/272 | 17/267 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 11/272 | 3/267 |
| AnaemiaBlood and lymphatic system disorders | 10/272 | 7/267 |
| Febrile neutropeniaBlood and lymphatic system disorders | 10/272 | 6/267 |
| Neutrophil count decreasedInvestigations | 3/272 | 8/267 |
| VomitingGastrointestinal disorders | 5/272 | 7/267 |
| Platelet count decreasedInvestigations | 0/272 | 7/267 |
| Acute kidney injuryRenal and urinary disorders | 4/272 | 7/267 |
| COVID-19Infections and infestations | 7/272 | 5/267 |
| DiarrhoeaGastrointestinal disorders | 3/272 | 6/267 |
| Event | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 138/272 | 141/267 |
| NauseaGastrointestinal disorders | 107/272 | 106/267 |
| ConstipationGastrointestinal disorders | 71/272 | 89/267 |
| Decreased appetiteMetabolism and nutrition disorders | 80/272 | 83/267 |
| PruritusSkin and subcutaneous tissue disorders | 27/272 | 80/267 |
| FatigueGeneral disorders | 75/272 | 78/267 |
| RashSkin and subcutaneous tissue disorders | 44/272 | 75/267 |
| AstheniaGeneral disorders | 64/272 | 55/267 |
| Neutrophil count decreasedInvestigations | 64/272 | 38/267 |
| DiarrhoeaGastrointestinal disorders | 58/272 | 50/267 |
Full Analysis Set (FAS) included all randomized participants whether or not the participants received the assigned treatment.
| Age, Continuous(years) | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy | Total |
|---|---|---|---|
| Mean | 63.4 ± 9.3 | 63.9 ± 9.4 | 63.6 ± 9.3 |
| Sex: Female, Male(Participants) | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy | Total |
|---|---|---|---|
| Female | 104 | 85 | 189 |
| Male | 169 | 184 | 353 |
| Ethnicity (NIH/OMB)(Participants) | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy | Total |
|---|---|---|---|
| Hispanic or Latino | 39 | 28 | 67 |
| Not Hispanic or Latino | 229 | 237 | 466 |
| Unknown or Not Reported | 5 | 4 | 9 |
| Race (NIH/OMB)(Participants) | Placebo + Pembrolizumab + Chemotherapy | Tiragolumab + Atezolizumab + Chemotherapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 12 | 10 | 22 |
| Asian | 89 | 87 | 176 |
| Native Hawaiian or Other Pacific Islander | 3 | 1 | 4 |
| Black or African American | 2 | 4 | 6 |
| White | 163 | 165 | 328 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 2 | 6 |
Showing the first 100 of 127 sites across 21 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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
Supporting information: Study protocol, Sap
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Carcinoma, Non-Small-Cell Lung→
Hoffmann-La Roche