Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

NCT04665856 | Active Not Recruiting Phase 3 Results FDA Drug

• 1 other identifier: YO42373
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 16

Brief Summary

The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with untreated extensive-stage small cell lung cancer.

Conditions

Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set (PAS)

  PFS was defined as time from randomization to the first occurrence of disease progression (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm).

  Up to 32.3 months

• Overall Survival (OS) in the PAS

  OS was defined as the time from the date of randomization to the date of death from any cause.

  Up to 32.3 months

Secondary Outcomes (18)

• PFS in the FAS

  Up to 32.3 months

• OS in the FAS

  Up to 32.3 months

• Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS

  Up to 32.3 months

• Investigator-Assessed Confirmed ORR in the FAS

  Up to 32.3 months

• Investigator-Assessed Duration of Response (DOR) in the PAS

  Up to 32.3 months

Study Arms (2)

Tiragolumab + Atezolizumab + Carboplatin and Etoposide

EXPERIMENTAL

Induction treatment with tiragolumab plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab plus atezolizumab for 21-day cycles.

Drug: Tiragolumab; Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide

Placebo + Atezolizumab + Carboplatin and Etoposide

PLACEBO COMPARATOR

Induction treatment with placebo plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo plus atezolizumab for 21-day cycles

Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide; Drug: Tiragolumab Matching Placebo

Interventions

Tiragolumab DRUG

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

Tiragolumab + Atezolizumab + Carboplatin and Etoposide

Atezolizumab DRUG

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

Placebo + Atezolizumab + Carboplatin and Etoposide; Tiragolumab + Atezolizumab + Carboplatin and Etoposide

Carboplatin DRUG

Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.

Placebo + Atezolizumab + Carboplatin and Etoposide; Tiragolumab + Atezolizumab + Carboplatin and Etoposide

Etoposide DRUG

Etoposide 100 mg/m\^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.

Placebo + Atezolizumab + Carboplatin and Etoposide; Tiragolumab + Atezolizumab + Carboplatin and Etoposide

Tiragolumab Matching Placebo DRUG

Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.

Placebo + Atezolizumab + Carboplatin and Etoposide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the modified Veterans Administration Lung Study Group (VALG) staging system
• No prior systemic treatment for ES-SCLC
• For participants who have received prior chemoradiotherapy for limited-stage SCLC must have had treatment with curative intent and a treatment-free interval of at least 6 months between the last dose/cycle of chemotherapy, thoracic radiotherapy, or chemoradiotherapy and the diagnosis of ES-SCLC
• Measurable diseases as defined by RECIST v1.1
• Submission of a pre-treatment tumor tissue sample
• Adequate hematologic and end-organ function
• Participants not receiving therapeutic anticoagulation with International Normalized Ratio (INR) and Activated Clotting Time (aPTT) \</= 1.5 x ULN
• Participants receiving therapeutic anticoagulation: stable anticoagulant regimen
• Negative Human Immunodeficiency Virus (HIV) test at screening
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) and/or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test
• Negative Epstein-Barr virus (EBV) viral capsid antigen (VCA) IgM test or negative EBV polymerase chain reaction (PCR) test at screening
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs

You may not qualify if:

• Symptomatic or actively progressing central nervous system (CNS) metastases
• Spinal cord compression
• Leptomeningeal disease
• Uncontrolled pleural effusion, pericardial effusion, or ascites
• Uncontrolled or symptomatic hypercalcemia
• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
• Malignancies other than SCLC within 5 years prior to randomization
• Active or history of autoimmune disease or immune deficiencies
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computer Tomography (CT) scan
• Known active tuberculosis, Current treatment with anti-viral therapy for HBV or HCV
• Severe chronic or active infection
• Treatment with therapeutic oral or IV antibiotics
• Significant cardiovascular disease
• Major surgical procedure other than for diagnosis
• Prior allogeneic bone marrow transplantation or solid organ transplant

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (16)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Beijing Chest Hospital

Beijing, 101149, China

Location

the First Affiliated Hospital of Bengbu Medical College

Bengbu, 233000, China

Location

the First Hospital of Jilin University

Changchun, 130021, China

Location

Fujian Provincial Cancer Hospital

Fuzhou, 350014, China

Location

Cancer Center of Guangzhou Medical University

Guangzhou, 510000, China

Location

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, 310016, China

Location

Zhejiang Cancer Hospital

Hangzhou, 310022, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

The 1st Affiliated Hospital of Nanchang Unversity

Nanchang, 330006, China

Location

Shanghai Chest Hospital

Shanghai, 200000, China

Location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

Location

Cancer Hospital of Shantou University Medical College

Shantou, 515041, China

Location

Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430022, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Tiragolumab; atezolizumab; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: December 21, 2020
• Primary Completion: August 31, 2023
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 13, 2026
• Results First Posted: October 29, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (16)