A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF ATEZOLIZUMAB IN PATIENTS WITH PD L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Phase 2

Completed

• Conditions: IET-KLEINCELLIG LONGCARCINOOM (NSCLC); Lungcancer; non small cell lung cancer

• Registration Number: NL-OMON45051
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 13

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 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 ;* For female patients of childbearing potential and male patients with partners of
childbearing potential, agreement (by patient and/or partner) to use a highly
effective form(s) of contraception

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified