Prospective Clinicogenomic Program

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

— PCG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180176
• Other study ID #: GX41563
• Status: Completed
• Phase: Phase 4
• Start date: December 13, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 945
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-Small Cell Lung Cancer (NSCLC)
• Small Cell Lung Carcinoma
• Small-Cell Lung Cancer (SCLC)

Intervention

Other:
• Blood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.

Locations

Country	Name	City	State
United States	University Cancer & Blood Center, LLC; Research	Athens	Georgia
United States	Piedmont Cancer Institute, PC	Atlanta	Georgia
United States	Alabama Oncology	Birmingham	Alabama
United States	Ironwood Cancer & Research Centers	Chandler	Arizona
United States	SCRI Tennessee Oncology Chattanooga	Chattanooga	Tennessee
United States	Regional Cancer Care Associates LLC, Central Jersey Division	East Brunswick	New Jersey
United States	Hematology Oncology Associates of Central New York	East Syracuse	New York
United States	Florida Cancer Specialists; Department of Oncology	Fort Myers	Florida
United States	Fort Wayne Med Oncology & Hematology Inc	Fort Wayne	Indiana
United States	Hematology Oncology Associates of Fredericksburg, Inc.	Fredericksburg	Virginia
United States	Cancer & Hematology Centers of Western Michigan	Grand Rapids	Michigan
United States	Clearview Cancer Institute	Huntsville	Alabama
United States	Jackson Oncology Associates, PLLC	Jackson	Mississippi
United States	Southeast Nebraska Cancer Ctr	Lincoln	Nebraska
United States	Tennessee Oncology	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	West Clinic	New York	New York
United States	National Translational Research Group	Port Jefferson Station	New York
United States	Virginia Cancer Institute - Richmond	Richmond	Virginia
United States	Florida Cancer Specialist, North Region	Saint Petersburg	Florida
United States	SCRI Florida Cancer Specialists PAN	Tallahassee	Florida
United States	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma
United States	Florida Cancer Specialists	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Genentech, Inc.	Flatiron Health, Inc.; Foundation Medicine, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Potential Eligible Participant Enrollment		Up to 5 years
Primary	Proportion of Enrolled Participants Submitting Sufficient Blood Samples		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	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.