PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER MedDRA version: 19.1 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 Code: MPDL3280A-RO5541267
Pharmaceutical Form: Solution for infusion
Current Sponsor code: MPDL3280A
Other descriptive name: RO5541267
Concentration unit: mg/ml milligram(s)/millilitre
Concent
Sponsors
F. Hoffmann-La Roche Ltd
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 assay based on PD-L1 expression on tumor infiltrating immune cells and/or tumor cells performed by a central laboratory • ECOG performance status of 0 or 1 • Life expectancy > 12 weeks • Measurable disease, as defined by RECIST v1.1 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 545 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: • 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 • Leptomeningeal disease • History of auto-immune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The co-primary endpoints of this study will be IRF-assessed ORR according to RECIST v1.1 and investigator-assessed ORR according to modified RECIST criteria .;Timepoint(s) of evaluation of this end point: Please refer to section E.5.1;Main Objective: The primary objective for this study is to evaluate the efficacy of MPDL3280A in patients with programmed cell death-1 ligand 1 (PD-L1)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC), as measured by: • Independent review facility (IRF)-assessed objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 ;Secondary Objective: • To evaluate progression-free survival (PFS) and duration of response (DOR) according to RECIST v1.1 as assessed by IRF and according to modified RECIST as assessed by the investigators • To evaluate ORR, DOR, and PFS according to RECIST v1.1 as assessed by the investigators • To evaluate overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • PFS assessed by IRF per RECIST v1.1 • PFS assessed by investigator per modified RECIST • OS ;Timepoint(s) of evaluation of this end point: Please refer to section E.5.2 | — |
Countries
Belgium, Bulgaria, Canada, France, Germany, Italy, Netherlands, Slovenia, Spain, Switzerland, Turkey, United Kingdom
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
Outcome results
None listed