A Study of Atezolizumab With or Without Tiragolumab Consolidation in Limited Stage Small Cell Lung Cancer

NCT ID: NCT04308785

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-07-25

Brief Summary

This is a multicenter, double-blind, placebo-controlled, randomized, phase II study to investigate the efficacy and safety of Atezolizumab with or without Tiragolumab as consolidation therapy in participants with limited stage small cell lung cancer who have not progressed during/after chemoradiotherapy.

Detailed Description

Participants can receive concurrent or sequential chemoradiotherapy (CRT) as per local standard of care, but they must be randomized within 6 weeks from completion of chemoradiotherapy. Participants should receive 4 cycles of chemotherapy and radiotherapy dose of 56-64 Gy (once daily) before randomization, and those participants who have not progressed during/after CRT will be stratified by response to CRT, radiotherapy timing, and be randomized in a 1:1 ratio to Atezolizumab+Tiragolumab arm or Atezolizumab+placebo arm.

Conditions

Carcinoma, Small Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm A: Atezolizumab + Tiragolumab

Participants will receive atezolizumab + tiragolumab intravenously on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and tiragolumab treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered at a dose of 1200 mg intravenously on the first day of each 21-day cycle.

Tiragolumab

Intervention Type: DRUG

Tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each 21-day cycle.

Arm B: Atezolizumab + Placebo

Participants will receive atezolizumab + placebo on the first day of each cycle. One cycle of therapy will be defined as 21 days. Atezolizumab and placebo treatment will continue up to 17 doses unless investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab will be administered at a dose of 1200 mg intravenously on the first day of each 21-day cycle.

Placebo

Intervention Type: OTHER

Placebo matching to tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each cycle.

Interventions

Atezolizumab

Atezolizumab will be administered at a dose of 1200 mg intravenously on the first day of each 21-day cycle.

Intervention Type: DRUG

Tiragolumab

Tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each 21-day cycle.

Intervention Type: DRUG

Placebo

Placebo matching to tiragolumab will be administered at a dose of 600 mg intravenously on the first day of each cycle.

Intervention Type: OTHER

Other Intervention Names

Tecentriq

Eligibility Criteria

Inclusion Criteria

• Signed Informed Consent Form
• ECOG performance status of 0 or 1
• Histologically confirmed limited-stage SCLC.
• Patients who have not progressed during/after chemoradiotherapy.
• Concurrent or sequential chemoradiotherapy per local clinical practice must have been completed within 6 weeks prior to the first study treatment. If concurrent CRT is used, at least two cycles of chemotherapy should have been conducted during radiotherapy. If sequential radiotherapy is used, induction chemotherapy should be given 2 cycles of chemotherapy before thoracic radiotherapy.
• Adequate hematologic and end organ function.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the final dose of atezolizumab or placebo, and 90 days after the final dose of tiragolumab or placebo, and 6 months for chemotherapy after the last dose of chemotherapy treatment, whichever is later.
• For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm.
• Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior therapy.
• Patients must submit a pre-treatment tumor tissue sample.

Exclusion Criteria

• Histology mixtured or Extensive-stage SCLC (per the Veterans Administration Lung Study Group (VALG) staging system).
• Uncontrolled pleural effusion or pericardial effusion requiring recurrent drainage procedures
• Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease
• Malignancies other than SCLC within 5 years prior to study treatment initiation, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab and 90 days after the final dose of tiragolumab, and 6 months for chemotherapy after the final dose of the chemotherapy treatment.
• Active or history of autoimmune disease or immune deficiency
• Uncontrolled or symptomatic hypercalcemia
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
• Positive test result for HIV
• Patients with active hepatitis B or hepatitis C virus
• Active tuberculosis
• Severe infections within 4 weeks prior to study treatment initiation, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Significant cardiovascular disease
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA4, anti-tigit, anti-PD-1, and anti-PD-L1 therapeutic antibodies
• Unresolved toxic effects of grade 2 or higher (CTCAE 5.0), including grade ≥ 2 pneumonitis from previous therapy
• Active EBV infection or known or suspected chronic active EBV infection at screening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Beijing Cancer Hospital

Beijing, , China

Jilin Cancer Hospital

Changchun, , China

Hu Nan Provincial Cancer Hospital

Changsha, , China

Sichuan Cancer Hospital

Chengdu, , China

Southwest Hospital , Third Military Medical University

Chongqing, , China

Fujian Cancer Hospital

Fuzhou, , China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, , China

Sun Yet-sen University Cancer Center

Guangzhou, , China

Harbin Medical University Cancer Hospital

Harbin, , China

Anhui Province Cancer Hospital

Hefei, , China

Shandong Cancer Hospital

Jinan, , China

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, , China

Fudan University Shanghai Cancer Center; Medical Oncology

Shanghai, , China

Tianjin Cancer Hospital

Tianjin, , China

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

Wuhan, , China

First Affiliated Hospital of Medical College of Xi'an Jiaotong University

Xi'an, , China

Henan Cancer Hospital

Zhengzhou, , China

Countries

China

Other Identifiers

ML41257

Identifier Type: -

Identifier Source: org_study_id