Prospective Clinicogenomic Program (PCG)

Genentech

Status and phase: Completed; Phase 4

Conditions: Small-Cell Lung Cancer (SCLC); Non-Small Cell Lung Cancer (NSCLC)

Treatments: Other: Blood Draw

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04180176

GX41563

Details and patient eligibility

About

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.

Enrollment: 945 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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945 participants in 2 patient groups

All-Comer Cohort

Experimental group

Description:

Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.

Treatment:

Other: Blood Draw

Front-line Immunotherapy Re-enrollment Cohort

Experimental group

Description:

Participants with mNSCLC or ES-SCLC that have received front-line treatment as defined by the protocol will give blood samples at three separate timepoints for ctDNA profiling.

Treatment:

Other: Blood Draw