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

NCT04308785 | Terminated Phase 2 DMC

• 1 other identifier: ML41257
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 17

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.

Conditions

Carcinoma, Small Cell Lung

Outcome Measures

Primary Outcomes (1)

• Investigator Assessed Progression-Free Survival (PFS) in the Intent-To-Treat (ITT) Population

  PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be calculated based on disease status evaluated by the investigator according to RECIST v1.1.

  Randomization up to approximately 48 months

Secondary Outcomes (18)

• Overall Survival (OS) in the ITT Population

  Randomization up to approximately 48 months

• PFS Rate at 1 Year and 2 Years in the ITT Ppulation

  Baseline to 1 Year and 2 Years

• OS Rate at 1 Year, 2 Years and 3 Years in the ITT Population

  Baseline to 1 Year, 2 Years and 3 Years

• Objective Response Rate (ORR) in the ITT Population

  Randomization up to approximately 48 months

• Duration of Response (DOR) in the ITT Population

  Time from first documentation of complete response (CR) or partial response (PR) up to approximately 48 months

Study Arms (2)

Arm A: Atezolizumab + Tiragolumab

EXPERIMENTAL

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).

Drug: Atezolizumab; Drug: Tiragolumab

Arm B: Atezolizumab + Placebo

EXPERIMENTAL

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).

Drug: Atezolizumab; Other: Placebo

Interventions

Atezolizumab DRUG

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

Also known as: Tecentriq

Arm A: Atezolizumab + Tiragolumab; Arm B: Atezolizumab + Placebo

Tiragolumab DRUG

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

Arm A: Atezolizumab + Tiragolumab

Placebo OTHER

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

Arm B: Atezolizumab + Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Jilin Cancer Hospital

Changchun, 132013, China

Location

Hu Nan Provincial Cancer Hospital

Changsha, 410006, China

Location

Sichuan Cancer Hospital

Chengdu, 610041, China

Location

Southwest Hospital , Third Military Medical University

Chongqing, 400038, China

Location

Fujian Cancer Hospital

Fuzhou, 350014, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510120, China

Location

Sun Yet-sen University Cancer Center

Guangzhou, 510663, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

Anhui Province Cancer Hospital

Hefei, 230031, China

Location

Shandong Cancer Hospital

Jinan, 250117, China

Location

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, 530021, China

Location

Fudan University Shanghai Cancer Center; Medical Oncology

Shanghai, 201315, China

Location

Tianjin Cancer Hospital

Tianjin, 300060, China

Location

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

Wuhan, 430023, China

Location

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

Xi'an, 710061, China

Location

Henan Cancer Hospital

Zhengzhou, 450008, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab; Tiragolumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 16, 2020
• Study Start: December 1, 2021
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (17)