A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program

Genentech, Inc.23 sites in 1 country945 target enrollmentDecember 13, 2019

ConditionsNon-Small Cell Lung Cancer (NSCLC)Small-Cell Lung Cancer (SCLC)

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Genentech, Inc.
Enrollment: 945
Locations: 23
Primary Endpoint: Proportion of Potential Eligible Participant Enrollment
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) planning to start standard-of-care (SOC) systemic anti-cancer treatment. The study will also examine ctDNA status over the course of treatment as a predictor of response to therapy.

Registry

clinicaltrials.gov

Start Date

December 13, 2019

End Date

November 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genentech, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Documented diagnosis of mNSCLC or ES-SCLC
•Planned initiation of SOC systemic anti-cancer treatment
•Front-Line Immunotherapy Cohort: Received front-line treatment of an immune blockade therapy including anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibody on Protocol GX41563

Exclusion Criteria

•Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent

Outcomes

Primary Outcomes

Proportion of Potential Eligible Participant Enrollment

Time Frame: Up to 5 years

Proportion of Enrolled Participants Submitting Sufficient Blood Samples

Time Frame: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.

Secondary Outcomes

Blood Level of ctDNA(At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.)