This is an observational study to collects blood samples and tumor tissue from adults with relapsed small-cell lung cancer (SCLC) receiving 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.
18 years of age or older
Confirmed pathologic diagnosis of active SCLC or neuroendocrine cancer.
Relapsed small cell lung cancer (SCLC) planning to receive commercial DLL3 bispecific T cell engager.
Willing to provide informed consent.
Prisoners or incarcerated patients
Those with cognitive impairments lacking decision-making capacity are excluded.
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.
The sample population will include adult patients with relapsed small cell lung cancer (SCLC) receiving care at The Ohio State University Comprehensive Cancer Center - James Cancer Hospital (OSUCCC - The James).
Cohort
Prospective
Biospecimen collection
Procedure/SurgeryUndergo blood and tissue sample collection
Feasibility of obtaining paired tumor samples and serial blood collection
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
Investigator-assessed objective response rate (ORR)
The proportion of patients achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1
Progression-free survival (PFS
The time from treatment initiation until disease progression or death from any cause
Overall survival (OS)
The time from treatment initiation until death from any cause
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Ohio State University Comprehensive Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator
