Prospective Multiomic Analysis in Small-Cell Lung Cancer

NCT07795411 | Recruiting

• 1 other identifier: OSU-25319
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Cell Lung Cancer ( SCLC ); Lung Cancer; Small Cell Cancer Of The Lung; Small-Cell Lung Cancer (SCLC)

Keywords

relapsed small-cell lung cancer; multiomic analysis

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 3 years

Secondary Outcomes (3)

• Investigator-assessed objective response rate (ORR)

  Up to 3 years

• Progression-free survival (PFS

  Up to 3 years

• Overall survival (OS)

  Up to 3 years

Study Arms (1)

Relapsed SCLC Patients

Blood and tissue samples will be collected at baseline, during treatment, and at disease progression, in concordance with routine clinical visits and imaging assessments.

Procedure: Biospecimen collection

Interventions

Biospecimen collection PROCEDURE

Undergo blood and tissue sample collection

Relapsed SCLC Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.
• 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
• Patients with multiple primary malignancies, recurrent lung cancer, or mixed histology are not excluded.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue and blood samples will be retained.

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Asrar Alahmadi, MBBS, MAS-CR

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): November 25, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)