NON-SMALL CELL LUNG CANCER AFTER PLATINUM FAILURE 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: •Histologically or cytologically documented locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC •Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment •Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen •Measurable disease, as defined by RECIST v1.1 •ECOG performance status of 0 or 1 •Life expectancy > 12 weeks • 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 200
Exclusion criteria
Exclusion criteria: •Received therapeutic oral or IV antibiotics within 2 weeks prior to randomization •Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis •Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such a live attenuated vaccine will be required during the study •Positive test for HIV •Untreated or symptomatic central nervous system metastases •History of autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine if Atezolizumab treatment results in superior OS compared with docetaxel treatment in patients with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen ; Secondary Objective: The secondary efficacy objectives of this study are: - To evaluate efficacy of atezolizumab compared with docetaxel with respect to anti-tumor effects as measured by PFS per investigator using RECIST v1.1 - To evaluate the efficacy of atezolizumab compared with docetaxel with respect to antitumor effects as measured by ORR per investigator using RECIST v1.1 - To evaluate efficacy of atezolizumab compared with docetaxel with respect to anti-tumor effects as measured by DOR per RECIST v1.1 for responding patients ; Primary end point(s): The primary efficacy endpoint for this trial is duration (in months) of OS (overall survival). OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. Data for patients who are not reported as having died at the time of analysis will be censored at the date they were last known to be alive. Patients who do not have post-baseline information will be censored at the date of randomization plus 1 day. The OS analyses will be performed for the PP (Primary Population) at the PAT (Primary Analysis Time) and for the SP (Secondary Population) at the SAT (Secondary Analysis Time). ; Timepoint(s) of evaluation of this end point: Time from the date of randomization to the date of death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS is defined as the time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first. Disease progression will be determined based on investigator assessment using RECIST v1.1. ;Timepoint(s) of evaluation of this end point: Time (in months) between the date of randomization and the date of first documented disease progression or death, whichever occurs first | — |
Countries
Argentina, Austria, Brazil, Canada, Chile, Finland, France, Germany, Greece, Guatemala, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Serbia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd.
Outcome results
None listed