Lung Cancer, Small Cell Cancer Of The Lung, Small Cell Lung Cancer ( SCLC ), Small-Cell Lung Cancer (SCLC)
Conditions
Keywords
relapsed small-cell lung cancer, multiomic analysis
Brief summary
This is an observational study to collects blood samples and tumor tissue from adults with relapsed small-cell lung cancer (SCLC) receicing standard of care commercial DLL3 T cell engager. The goal of the study is to understand the changes in tumor markers over time and examine whether these changes are associated with clinical outcomes. Participants will provide blood samples and, when clinically feasible, tumor tissue during routine care visits, treatment, and imaging assessments. The study does not assign cancer treatment.
Detailed description
The goal of this study is to prospectively and longitudinally collect blood and tumor tissue from patients with relapsed small cell lung cancer (SCLC) receicing standard of care commercial DLL3 T cell engager. We will do a comprehensive multi-omic analysis integrating genomic, transcriptomic, proteomic, and clinical data to investigate mechanisms of resistance, and identify potential therapeutic vulnerabilities. Primary objective is to assess the feasibility of obtaining paired tumor samples and serial blood collection in relapsed ES-SCLC patients Secondary objectives are to characterize longitudinal SCLC tumor-associated markers, including DLL3; evaluate concordance between plasma and tissue, ctDNA, protomics and explore associations between molecular findings and clinical outcomes.
Interventions
PROCEDUREBiospecimen collection
Undergo blood and tissue sample collection
Sponsors
Ohio State University Comprehensive Cancer Center
Genentech, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Confirmed pathologic diagnosis of active SCLC or neuroendocrine cancer. 3. Relapsed small cell lung cancer (SCLC) planning to receive commercial DLL3 bispecific T cell engager. 4. Willing to provide informed consent. 5. Willing to provide blood samples and undergo tissue biopsy at various time points throughout the study, collected in concurrence with treatment cycles and/or imaging visits 6. Patients with multiple primary malignancies, recurrent lung cancer, or mixed histology are not excluded. 7. Patients who have contraindications or are unable to receive immunotherapy will be eligible for the study, and their samples will be used for comparison and control.
Exclusion criteria
1. Prisoners or incarcerated patients 2. Those with cognitive impairments lacking decision-making capacity are excluded. 3. There will be no specific restrictions with respect to performance status, organ function, or prior/concurrent modes of therapy other than that the patient must be able to tolerate venipuncture and any planned interventional radiology or surgical procedures deemed necessary by their treating physicians.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of obtaining paired tumor samples and serial blood collection | Up to 3 years | The feasibility rate is defined as the proportion of enrolled patients who obtained paired pre- and post-treatment biopsies with good quality (≥30% cellularity) and were compliant with serial blood samples collection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 3 years | The time from treatment initiation until death from any cause |
| Investigator-assessed objective response rate (ORR) | Up to 3 years | The proportion of patients achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 |
| Progression-free survival (PFS | Up to 3 years | The time from treatment initiation until disease progression or death from any cause |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORAsrar Alahmadi, MBBS, MAS-CR
Ohio State University Comprehensive Cancer Center
Outcome results
None listed