A Study of Atezolizumab in Combination With Bevacizumab in Patients With EGFR Mutation Positive Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer

NCT04426825 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ML41256
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 10

Brief Summary

This is an open-label, single-arm, phase II, multicenter study designed to evaluated the efficacy and safety of atezolizumab in combination with bevacizumab in PD-L1-selected patients with Stage IIIB-IV Non-Squamous NSCLC harbored EGFR mutation after EGFR TKI therapy.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate (ORR) was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions \>=4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

  Baseline up to approximately 10 months

Secondary Outcomes (17)

• Duration of Objective Response (DOR)

  Baseline up to approximately 2.5 years

• Time to Response (TTR)

  Baseline up to approximately 2.5 years

• Disease Control Rate (DCR)

  Baseline up to approximately 2.5 years

• Overall Survival (OS)

  Baseline until death due to any cause (up to approximately 2.5 years)

• Progression-Free Survival (PFS)

  Baseline up to approximately 2.5 years

Study Arms (1)

Atezolizumab plus Bevacizumab

EXPERIMENTAL

Participants will receive atezolizumab plus bevacizumab intravenously on Day 1 of each cycle. Treatment will continue until progressive disease, unacceptable toxicity, or death.

Drug: Atezolizumab; Drug: Bevacizumab

Interventions

Atezolizumab DRUG

Atezolizumab will be administered at a dose of 1200 mg intravenously on Day 1 of each 21-day cycle.

Also known as: Tecentriq

Atezolizumab plus Bevacizumab

Bevacizumab DRUG

Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

Also known as: Avastin

Atezolizumab plus Bevacizumab

Eligibility Criteria

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

You may qualify if:

• Life expectancy ≥ 10 months
• Histologically or cytologically confirmed stage IIIB, IIIC, or IV non-squamous NSCLC. Patients with tumors of mixed histology are eligible if the major histological component appears to be non-squamous.
• No prior treatment for Stage IIIB, IIIC, or IV non-squamous NSCLC, with the following exceptions:
• Patients with a sensitizing mutation in the EGFR gene must have experienced disease progression or were intolerant to treatment with one or more EGFR TKIs. Patients who have progressed on or were intolerant to first-line osimertinib or other thirdgeneration EGFR TKIs are eligible.
• Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs, and who have no evidence of the EGFR T790M mutation after TKI therapy are eligible.
• Patients who have progressed on or were intolerant to first- or second-generation EGFR TKIs and who have evidence of the T790M mutation must have also progressed on or were intolerant to osimertinib to be eligible.
• TKIs approved for treatment of NSCLC discontinued \>7 days prior to enrollment.
• Measurable disease per RECIST v1.1. PD-L1 expression of ≥1% as documented through central testing of a representative tumor tissue specimen either from previously obtained archival tumor tissue or tissue obtained from a biopsy at screening
• ECOG Performance Status of 0-1
• Adequate hematologic and end-organ function
• Negative HIV test at screening
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs.

You may not qualify if:

• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
• History of leptomeningeal disease
• Prior chemotherapy or other systemic therapy for stage IIIB, IIIC, or IV disease
• 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
• Active tuberculosis
• Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
• History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
• Prior allogeneic stem cell or solid organ transplantation
• Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
• Current treatment with anti-viral therapy for HBV
• Treatment with investigational therapy within 28 days prior to initiation of study treatment
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Beijing Hospital; Internal Medicine-Oncology

Beijing, 100730, China

Location

Beijing Chest Hospital; Oncology Department

Beijing, 101149, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

Sun Yet-sen University Cancer Center

Guangzhou, 510663, China

Location

Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

Hangzhou, 310022, China

Location

Harbin Medical University Cancer Hospital

Harbin, 150081, China

Location

Shandong Cancer Hospital

Jinan, 250117, China

Location

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, 530021, China

Location

The Affiliated Hospital of Medical College Qingdao University

Qingdao, 266000, China

Location

Related Publications (1)

• Fang W, Fang J, Tian P, Fan Y, Yu Q, Zhang X, Wang Z, Liu X, Shi Y, Zhang L. Efficacy and Safety of Atezolizumab Plus Bevacizumab in Patients With Advanced NSCLC Who Received Pretreatment With EGFR-TKIs (ML41256): A Multicenter, Prospective, Single-Arm, Phase 2 Trial. Cancer Med. 2025 Dec;14(24):e71469. doi: 10.1002/cam4.71469.

  PMID: 41388935 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; Bevacizumab

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)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: September 9, 2020
• Primary Completion: January 19, 2022
• Study Completion: February 10, 2023
• Last Updated: May 21, 2024
• Results First Posted: April 13, 2023

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (10)