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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Participants will provide blood samples and, when clinically feasible, tumor tissue during routine care visits, treatment, and imaging assessments."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at changes in tumor markers, signs of cancer found in blood and tumor tissue, and how they relate to treatment results. It is for adults whose small-cell lung cancer has come back and who plan to receive a DLL3 T-cell engager, a drug that helps immune cells target cancer. The study does not choose cancer treatment; people who cannot receive immune-based treatment may also join for comparison.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have active small-cell lung cancer or neuroendocrine cancer, which starts in cells with nerve and hormone features, confirmed by a tissue test.
  • Have small-cell lung cancer that has come back and plan to receive an approved DLL3 T-cell engager drug.
  • Be willing to give informed consent, meaning you understand the study and agree to join.
  • Be willing to give blood samples and have biopsies, which remove small tissue samples, at different study visits. Tumor tissue is collected when medically possible.
  • You may join if you have more than one separate cancer, lung cancer that has come back, or a tumor with mixed cancer cell types.
  • You may also join if you cannot receive immune-based treatment. Your samples will be used for comparison.

Who can't join

  • You cannot join if you are in prison or jail.
  • You cannot join if problems with thinking prevent you from making decisions about joining.
  • You must be able to handle blood draws and any planned procedures your treating doctors say are needed. There are no other set limits on daily activity level, how well your organs work, or past or current treatments.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

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