A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

NCT05047250 | Active Not Recruiting Phase 3

• 1 other identifier: ML42606
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 18

Brief Summary

This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival (OS) is defined as the time from atezolizumab initiation to death from any cause.

  Atezolizumab initiation to death from any cause (up to approximately 28 months)

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), (up to approximately 28 months)

• OS Rate at 1-Year

  Atezolizumab initiation to 1-year

• OS Rate at 2-Year

  Atezolizumab initiation to 2-year

• Objective Response Rate (ORR)

  Randomization up to approximately 34 months

• Duration of Response (DOR)

  Randomization up to approximately 34 months

Study Arms (1)

Atezolizumab

EXPERIMENTAL

Participants will receive IV infusion of atezolizumab on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.

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:

• ECOG performance status of 0 or 1.
• Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC.
• No prior treatment for Stage IV non-squamous or squamous NSCLC.
• Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy cycle.
• Tumor TC3 or IC3, as determined by SP142 performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening.
• Measurable disease, as defined by RECIST v1.1.
• Adequate hematologic and end-organ function.
• Life expectancy ≥3 months.
• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating.

You may not qualify if:

• Known sensitizing mutation in the EGFR gene or ALK fusion oncogene.
• Symptomatic, untreated, or actively progressing 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 enrollment.
• Current leptomeningeal disease.
• Uncontrolled tumor-related pain.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• Uncontrolled or symptomatic hypercalcemia.
• Malignancies other than NSCLC within 5 years prior to enrollment, 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 at least 5 months after the last dose of atezolizumab.
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
• Known allergy or hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
• Active or history of autoimmune disease or immune deficiency.
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
• Positive human immunodeficiency virus (HIV) test result at screening.
• Patients with active hepatitis B or active hepatitis C at screening.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (18)

Beijing Tiantan Hospital,Capital Medical University

Beijing, 100050, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

Location

Beijing Chest Hospital

Beijing, 101149, China

Location

The Third Xiangya Hospital Of Central South University

Changsha, 410013, China

Location

Daping Hospital of Third Military Medical University

Chongqing, 400042, China

Location

Fujian Cancer Hospital

Fuzhou, 350014, China

Location

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, 310016, China

Location

Anhui Province Cancer Hospital

Hefei, 230001, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022, China

Location

Linyishi Cancer Hospital

Linyi, 276034, China

Location

Nanjing Chest Hospital

Nanjing, 210029, China

Location

Shanghai Chest Hospital

Shanghai, 200000, China

Location

Cancer Hospital of Shantou University Medical College

Shantou, 515041, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, 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

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, 361003, 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: September 8, 2021
• First Posted: September 17, 2021
• Study Start: June 14, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (18)