Prospective Clinicogenomic Program
- Conditions
- Small-Cell Lung Cancer (SCLC)Non-Small Cell Lung Cancer (NSCLC)
- Interventions
- Other: Blood Draw
- Registration Number
- NCT04180176
- Lead Sponsor
- Genentech, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 945
- 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
- Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All-Comer Cohort Blood Draw Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling. Front-line Immunotherapy Re-enrollment Cohort Blood Draw 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.
- Primary Outcome Measures
Name Time Method 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. Proportion of Potential Eligible Participant Enrollment Up to 5 years
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (23)
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Ironwood Cancer & Research Centers
🇺🇸Chandler, Arizona, United States
University Cancer & Blood Center, LLC; Research
🇺🇸Athens, Georgia, United States
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Florida Cancer Specialists; Department of Oncology
🇺🇸Fort Myers, Florida, United States
Florida Cancer Specialist, North Region
🇺🇸Saint Petersburg, Florida, United States
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
SCRI Florida Cancer Specialists PAN
🇺🇸Tallahassee, Florida, United States
Piedmont Cancer Institute, PC
🇺🇸Atlanta, Georgia, United States
Fort Wayne Med Oncology & Hematology Inc
🇺🇸Fort Wayne, Indiana, United States
Jackson Oncology Associates, PLLC
🇺🇸Jackson, Mississippi, United States
Cancer & Hematology Centers of Western Michigan
🇺🇸Grand Rapids, Michigan, United States
Southeast Nebraska Cancer Ctr
🇺🇸Lincoln, Nebraska, United States
Regional Cancer Care Associates LLC, Central Jersey Division
🇺🇸East Brunswick, New Jersey, United States
National Translational Research Group
🇺🇸Port Jefferson Station, New York, United States
Hematology Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
Oklahoma Cancer Specialists and Research Institute
🇺🇸Tulsa, Oklahoma, United States
Virginia Cancer Institute - Richmond
🇺🇸Richmond, Virginia, United States
Hematology Oncology Associates of Fredericksburg, Inc.
🇺🇸Fredericksburg, Virginia, United States
West Clinic
🇺🇸New York, New York, United States
SCRI Tennessee Oncology Chattanooga
🇺🇸Chattanooga, Tennessee, United States