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
- Conditions
- Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: 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-HU
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 572
- 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 non-squamous NSCLC who have an unknown EGFR or ALK status will be required to be tested at prescreening/screening. Patients with squamous NSCLC who have an unknown EGFR or ALK status will not be required to be tested at prescreening/screening.
- 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
- Women who are not postmenopausal (>= 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
- For patients enrolled in the China extension phase: residence in the People's Republic of China
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
- Active or untreated CNS metastases as determined by CT or MRI evaluation during screening
- Leptomeningeal disease
- Uncontrolled tumour-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- Uncontrolled or symptomatic hypercalcemia
- 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
- Positive test for HIV
- Patients with active hepatitis B or hepatitis C
- Active tuberculosis
- Severe infections within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia
- 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
- Administration of a live, attenuated vaccine within 4 weeks before randomization, during treatment, or within 90 days following last dose of atezolizumab (for patients randomized to atezolizumab)
- Treatment with systemic immunostimulatory agents (including but not limited to interferons, IL-2) within 4 weeks or five half-lives of the drug, whichever is longer, prior to randomization
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor [anti-TNF] agents) within 2 weeks prior to randomization
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- History of allergic reactions to cisplatin, carboplatin, or other platinum-containing compounds
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method