Phase 3
N=490
A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer
Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04256421 ↗Enrolled (actual)
490
Serious AEs
44.7%
Results posted
Oct 2025
Primary outcome: Primary: Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) — 5.55; 5.36 months — p=0.3504
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tiragolumab (Drug); Atezolizumab (Drug); Carboplatin (Drug); Etoposide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator-assessed Progression-free Survival (PFS) in the Primary Analysis Set (PAS) |
5.55; 5.36 | 0.3504 |
| PRIMARY Overall Survival (OS) in the PAS |
13.14; 13.11 | 0.2859 |
| SECONDARY PFS in the FAS |
5.42; 5.06 | 0.4440 |
| SECONDARY OS in the FAS |
12.91; 12.75 | 0.4205 |
| SECONDARY Investigator-assessed Confirmed Objective Response Rate (ORR) in the PAS |
66.7; 73.5 | 0.1418 |
| SECONDARY Investigator-assessed Confirmed ORR in the FAS |
65.6; 70.8 | 0.2191 |
| SECONDARY Investigator-assessed Duration of Response (DOR) in the PAS |
5.59; 4.19 | — |
| SECONDARY Investigator-assessed DOR in the FAS |
5.11; 4.17 | — |
| SECONDARY Investigator-assessed PFS Rates at 6 Months and 12 Months in the PAS |
42.42; 35.15; 17.29; 14.21 | — |
| SECONDARY Investigator-assessed PFS Rates at 6 Months and 12 Months in the FAS |
37.95; 31.30; 14.07; 12.33 | — |
| SECONDARY OS Rates at 12 Months and 24 Months in the PAS |
57.74; 54.00; 27.68; 19.56 | 0.4580 |
| SECONDARY OS Rates at 12 Months and 24 Months in the FAS |
55.84; 52.82; 25.82; 20.53 | 0.5059 |
| SECONDARY Time to Confirmed Deterioration (TTCD) of European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire-Core 30 (QLQ-C30) Physical Functioning (PF) in the PAS |
19.35; 15.67 | 0.9819 |
| SECONDARY TTCD of EORTC QLQ-C30 Physical Functioning in the FAS |
19.35; 15.67 | 0.5122 |
| SECONDARY TTCD of EORTC QLQ-C30 Global Health Status (GHS)/Quality-of-life (QoL) in the PAS |
NA; NA | 0.3614 |
| SECONDARY TTCD of EORTC QLQ-C30 GHS/QoL in the FAS |
NA; NA | 0.1681 |
| SECONDARY Number of Participants With Adverse Events (AEs) |
245; 238 | — |
| SECONDARY Number of Participants With Severity of Cytokine-release Syndrome (CRS), as Determined by the American Society for Transplantation and Cell Therapy (ASTCT) Consensus Grading Scale |
1; 0 | — |
| SECONDARY Minimum Serum Concentration (Cmin) of Tiragolumab |
29.5; 46.5; 56.3; 76.3; 78.8; 96.4 | — |
| SECONDARY Cmin of Atezolizumab |
75.0; 75.4; 121; 125; 144; 155 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Tiragolumab |
188 | — |
| SECONDARY Cmax of Atezolizumab |
398; 405 | — |
| SECONDARY Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab |
2; 3; 3; 0 | — |
| SECONDARY Number of Participants With ADAs to Atezolizumab |
2; 1; 48; 22; 48; 22 | — |
Summary
This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH ( ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase:
* Arm A: Tiragolumab plus atezolizumab plus CE
* Arm B: Placebo plus atezolizumab plus CE
Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
- No prior systemic treatment for ES-SCLC
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Adequate hematologic and end-organ function
- Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
Exclusion Criteria
- Symptomatic or actively progressing central nervous system (CNS) metastases
- Malignancies other than small cell lung cancer (SCLC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
- Active or history of autoimmune disease or immune deficiency
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Severe infection at the time of randomization
- Treatment with any other investigational agent within 28 days prior to initiation of study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (anti-CTLA-4), anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to randomization
Data sourced from ClinicalTrials.gov (NCT04256421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.