Clinical study to evaluate atezolizumab (MPDL3280A) in patients with PD-L1- positive locally or metastatic non-small cell lung cancer

Phase 1

• Conditions: PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER; MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000177-69-BE
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-29
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified