Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC)
Conditions
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.
Interventions
OTHERBlood Draw
Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.
Sponsors
Flatiron Health, Inc.; Foundation Medicine, Inc.
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Potential Eligible Participant Enrollment | Up to 5 years |
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Outcome results
None listed