Prospective Clinicogenomic Program

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-Small Cell Lung Cancer (NSCLC), Small-Cell Lung Cancer (SCLC)

Intervention / Treatment
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* Other: Blood Draw


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All-Comer Cohort<br>Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling. | Other: Blood Draw<br>* Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.<br>|
| Experimental: Front-line Immunotherapy Re-enrollment Cohort<br>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. | Other: Blood Draw<br>* Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. |