Prospective Multiomic Analysis in Small-Cell Lung Cancer

Prospective Multiomic Analysis in Small-Cell Lung Cancer to Inform Therapeutic Vulnerabilities and Predict Clinical Outcomes: Deep Phenotyping of Relapsed SCLC Cohort

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Small-Cell Lung Cancer (SCLC); Small Cell Lung Cancer ( SCLC ); Small Cell Cancer Of The Lung
• Intervention / Treatment: Procedure: Biospecimen collection

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
      • Contact: Asrar Alahamadi, MBBS; Phone Number: 614-293-6786; Email: Asrar.Alahmadi@osumc.edu
      • Principal Investigator: Asrar Alahmadi, MBBS, MAS-CR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Undergo blood and tissue sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 3 years
Progression-free survival (PFS	The time from treatment initiation until disease progression or death from any cause	Up to 3 years
Overall survival (OS)	The time from treatment initiation until death from any cause	Up to 3 years

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Asrar Alahmadi, MBBS, MAS-CR, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): November 25, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 26, 2026
• First Submitted That Met QC Criteria: August 26, 2026
• First Posted (Actual): August 31, 2026

Study Record Updates

• Last Update Posted (Actual): August 31, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: relapsed small-cell lung cancer; multiomic analysis
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: OSU-25319

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No