Recruiting

Observational Study

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07795411

Conditions

Small Cell Cancer Of The Lung

Small Cell Lung Cancer ( SCLC )

Lung Cancer

Small-Cell Lung Cancer (SCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen collection

Study Details

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 Cancer Of The Lung

Small Cell Lung Cancer ( SCLC )

Lung Cancer

Small-Cell Lung Cancer (SCLC)

Study ID

NCT07795411

Start date

Nov 25, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Biospecimen collection

Undergo blood and tissue sample collection

Primary outcome measure

  • Feasibility of obtaining paired tumor samples and serial blood collection [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Asrar Alahmadi, MBBS, MAS-CR

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Keywords

  • relapsed small-cell lung cancer
  • multiomic analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.