A Study to Investigate the Safety and Efficacy of Atezolizumab in Previously-Treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT03922997 | Completed Phase 3

• 1 other identifier: ML40471
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 7

Brief Summary

This is a phase III, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in patients with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC) who have progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy).

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Serious Adverse Event Incidence Rates

  The incidence of serious adverse events (SAEs) related to atezolizumab.

  Baseline up to approximately 3 years

Secondary Outcomes (7)

• Overall Survival (OS) Rate

  Baseline to 2 years

• OS

  Baseline up to approximately 3 years

• Progression-Free Survival (PFS)

  Baseline up to approximately 3 years

• Objective Response Rate (ORR)

  Baseline up to approximately 3 years

• Duration of Response (DOR)

  Baseline up to approximately 3 years

Study Arms (1)

Atezolizumab

EXPERIMENTAL

Participants will receive atezolizumab intravenously on the first day of each cycle. Atezolizumab treatment will continue until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or patient decision to withdraw from therapy, or death (whichever occurs first).

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

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

Also known as: Tecentriq

Atezolizumab

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically documented Stage IIIb or Stage IV NSCLC that has progressed following standard systemic chemotherapy (including if given in combination with anti-PD-1 therapy or after anti-PD-1 as monotherapy). Patients with a previously detected EGFR mutation or ALK fusion oncogene will be excluded from this study. Overall, patients should not have received more than two lines of systemic chemotherapy. Patients who have discontinued first-line or second-line systemic chemotherapy, targeted therapy, or anti-PD-1 therapy due to intolerance are also eligible.
• The last dose of prior systemic anticancer therapy must have been administered ≥ 21 days prior to the first study treatment.
• The last dose of prior anti-PD-1 therapy must have been administered
• Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
• Patients with asymptomatic CNS metastases (treated or untreated), as determined by CT or MRI evaluation during screening and prior radiographic evaluation, are eligible
• ECOG performance status 0, 1, or 2
• Life expectancy ≥ 12 weeks
• Adequate hematologic and end-organ function
• For women of childbearing potential: agreement to remain abstinent 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 last dose of atezolizumab
• Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia and toxicities related to prior anti-PD-1-therapy

You may not qualify if:

• Patients with EGFR mutation or ALK fusion oncogene
• Symptomatic CNS metastases
• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥ 2 weeks prior to the first study treatment
• Leptomeningeal disease
• Uncontrolled pericardial effusion or ascites requiring recurrent drainage procedures
• Pregnant or lactating, or intending to become pregnant during the study
• Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease
• Significant cardiovascular disease
• Significant renal disorder requiring dialysis or indication for renal transplant
• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to study treatment initiation
• Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
• Prior allogeneic stem cell or solid organ transplantation

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Peking Union Medical College Hospital

Beijing, 100032, China

Location

Sichuan Cancer Hospital

Chengdu, 610041, China

Location

Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

Hangzhou, 310022, China

Location

Harbin Medical University Tumor Hospital; Department of Surgery; Pharmacy

Harbin, 150049, China

Location

Taizhou Hospital of Zhejiang Province

Linhai, 317000, China

Location

Fudan University Shanghai Cancer Center; Medical Oncology

Shanghai, 201315, China

Location

Cancer Hospital Affliated to Xinjiang Medical University

Ürümqi, 830011, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

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 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 22, 2019
• Study Start: July 3, 2019
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (7)