NON-SMALL CELL LUNG CANCER MedDRA version: 20.0 Level: LLT Classification code 10029514 Term: Non-small cell lung cancer NOS System Organ Class: 100000004864
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 337
Exclusion criteria
Exclusion criteria: - 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, may be allowed upon approval by the Medical Monitor •Low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor - 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 16 cycles of atezolizumab treatment compared with best supportive care as measured by disease-free survival (DFS) as assessed by the investigator. ;Secondary Objective: To evaluate the efficacy of 16 cycles of atezolizumab treatment compared with BSC as measured by OS;Primary end point(s): 1.-DFS, defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: •First recurrence of NSCLC, as determined by the investigator after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status •Occurrence of new primary NSCLC, as assessed by the investigator •Death from any cause;Timepoint(s) of evaluation of this end point: 1.-Approximately 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.-OS, defined as the time from randomization to death from any cause;Timepoint(s) of evaluation of this end point: 1.-Approximately 5 years | — |
Countries
Australia, Belgium, Canada, China, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain, Taiwan, Ukraine, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd
Outcome results
None listed