A PHASE III, OPEN-LABEL, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) COMPARED WITH BEST SUPPORTIVE CARE FOLLOWING LUNG CANCER RESECTION AND CHEMOTHERAPY FOR EARLY STAGE LUNG CANCER.
- Conditions
- ON-SMALL CELL LUNG CANCERMedDRA version: 21.1Level: LLTClassification code 10029514Term: Non-small cell lung cancer NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003205-15-NL
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1280
- A representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in paraffin block (preferred) or 15 (or more) unstained, freshly cut, serial sections (on slides) from an FFPE resected tumor specimen is required for participation in this study. This specimen must be accompanied by the associated pathology report
- ECOG performance status of 0 or 1
- Histological or cytological diagnosis of Stage IB (tumors = 4 cm)-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4-N0 1) non-small cell lung cancer (NSCLC)
- Eligible to receive a cisplatin-based chemotherapy regimen
- For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception during study treatment that results in a low failure rate of < 1% per year when used consistently and correctly. Female and male patients should continue contraceptive use for 6 months after the last dose of cisplatin-based chemotherapy (cisplatin plus vinorelbine, docetaxel, gemcitabine, or pemetrexed). Female patients treated with atezolizumab should continue contraception use for 5 months after the last dose. . Women must refrain from donating eggs during this same period
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 782
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 498
- Illness or condition that may interfere with a patient’s capacity to understand, follow, and/or comply with study procedures
- Pregnant and lactating women
- Treatment with prior systemic chemotherapy, with the following exceptions:
•Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment, is allowed
•Low-dose chemotherapy for non-malignant conditions is allowed
- Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
- Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment
- Known sensitivity to any component of the chemotherapy regimen the patient will be assigned to, or to mannitol
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Patients who have had prior anti-CTLA-4 treatment may be enrolled, provided the following requirements are met:
•Last dose of anti-CTLA-4 at least 6 weeks prior to randomization
•No history of severe immune-mediated adverse effects from anti-CTLA-4 (NCI CTCAE Grades 3 and 4)
- Known tumor PD-L1 expression status as determined by an IHC assay from other clinical studies (e.g., patients whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded)
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