A Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With a Platinum (Cisplatin or Carboplatin) in Combination With Either Pemetrexed or Gemcitabine for PD L1-Selected, Chemotherapy-Naive Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

Phase 1

• Conditions: Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC); MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-003083-21-DE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-08
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 555

Inclusion Criteria

- Age >= 18 years
- 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 known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene are excluded from the study.
- Patients with a history of treated asymptomatic CNS metastases are eligible provided they meet certain criteria
- Tumour PD-L1 expression as determined by an IHC assay performed by a central laboratory on previously obtained archival tumour tissue or tissue obtained from a biopsy at screening
- Measurable disease, as defined by RECIST v1.1
- Adequate hematologic and end-organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175

Exclusion Criteria

- Known sensitizing mutation in the EGFR gene or ALK fusion oncogene
- Active or untreated CNS metastases as determined by CT or MRI evaluation during screening
- Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- Patients with positive test for HIV, active hepatitis B or hepatitis C, or active tuberculosis
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- Treatment with any other investigational agent with therapeutic intent within 28 days prior to randomization
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified