EUCTR2013-000177-69-BEActive, not recruitingPhase 1
A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF ATEZOLIZUMAB (MPDL3280A) IN PATIENTS WITH PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Genentech, Inc.
- Enrollment
- 130
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 [< 1% per year] when used consistently and correctly) during the treatment period and to continue its use for 5 months after the last dose of atezolizumab
- •Inclusion Criteria Unique to Cohort 1:
- •- No prior chemotherapy for locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC
- •Inclusion Criteria Unique to Cohorts 2 and 3
- •- Disease progression during or following prior platinum-based chemotherapy for locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC
- •Inclusion Criteria Unique to Cohort 3
- •- Diagnosis of brain metastases by brain MRI or contrast-enhanced CT
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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
Investigators
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