PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Atezolizumab
Product Code: MPDL3280A-RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Atezolizumab
Sponsors
Genentech, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically or cytologically documented Stage IIIB (not eligible for definitive chemoradiotherapy), Stage IV, or recurrent NSCLC - PD-L1-positive status as determined by an IHC assay performed by a central laboratory - ECOG performance status of 0 or 1 - Measurable disease, as defined by RECIST v1.1 - For female patients of childbearing potential, agreement (by patient) to remain abstinent (refrain from heterosexual intercourse) or to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment - Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment - Known CNS disease, including treated brain metastases: Cohorts 1 and 2 - Leptomeningeal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective for this study is to evaluate the efficacy of atezolizumab in patients with PD-L1-positive locally advanced or metastatic NSCLC, as measured by investigator-assessed ORR according to modified RECIST; Secondary Objective: - To evaluate PFS and DOR according to modified RECIST - To evaluate the efficacy of Atezolizumab in patients with PD-L1-positive locally advanced or metastatic NSCLC, as measured by investigator-assessed ORR, DOR, PFS, where all response endpoints are determined according to RECIST 1.1 - To evaluate OS - To evaluate PFS in patients who experience a confirmed partial response (PR) or confirmed response CR per modified RECIST at any time on study treatment - To evaluate the safety and tolerability of Atezolizumab in patients with PD-L1-positive locally advanced or metastatic NSCLC - To characterize the pharmacokinetics of Atezolizumab - To evaluate the incidence and titers of ATAs against Atezolizumab and to explore the potential relationship of the immunogenicity response with pharmacokinetics, safety, and efficacy ;Primary end point(s): investigator overall response rate (ORR) per modified RECIST;Timepoint(s) of evaluation of this end point: timepoint for evaluation will be 6 months after approximately 130 patients have been enrolled; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ORR, duration of response (DOR), progression-free survival (PFS), and overall survival (OS) per RECIST v1.1,;Timepoint(s) of evaluation of this end point: timepoint for evaluation is same as for primary endpoint, with updated analysis approximately 12 months after the last patient is enrolled in the study | — |
Countries
Belgium, France, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
Outcome results
None listed