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NCT Number: NCT07795411

Prospective Multiomic Analysis in Small-Cell Lung Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location contact

Asrar Alahamadi, MBBS

CONTACT

[email protected]

614-293-6786

Asrar Alahmadi, MBBS, MAS-CR

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood and tissue sample collection

Primary outcomes

  1. Feasibility of obtaining paired tumor samples and serial blood collection

    Time frame: 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 outcomes

  1. Investigator-assessed objective response rate (ORR)

    Time frame: Up to 3 years

    The proportion of patients achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1

  2. Progression-free survival (PFS

    Time frame: Up to 3 years

    The time from treatment initiation until disease progression or death from any cause

  3. Overall survival (OS)

    Time frame: Up to 3 years

    The time from treatment initiation until death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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