A phase II multicenter, single-arm study of MPDL3280A in patients with PD-L1 positive locally advanced or metastatic non small cell lunch cancer

Phase 2

Recruiting

• Conditions: Lung cancer; Nonsmall Cell lung cancer; 10038666; 10029107

• Registration Number: NL-OMON44922
• Lead Sponsor: Genentech, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

• Age >= 18 years
• 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;For more detailed information please refer to protocol section 4.1

Exclusion Criteria

Cancer-Specific Exclusions
• 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;For more detailed information please refer to protocol section 4.1

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy outcome measure is investigator-assessed objective response<br /><br>(confirmed PR or confirmed CR) according to modified RECIST.</p><br>