Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Small Cell Cancer Of The Lung | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Small Cell Lung Cancer ( SCLC ) | Lung Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Relapsed SCLC Patients
- description
- Blood and tissue samples will be collected at baseline, during treatment, and at disease progression, in concordance with routine clinical visits and imaging assessments.
- interventionNames
- Procedure: Biospecimen collection
Primary outcomes (1)
- measure
- Feasibility of obtaining paired tumor samples and serial blood collection
- timeFrame
- Up to 3 years
- description
- 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 (3)
- measure
- Investigator-assessed objective response rate (ORR)
- timeFrame
- Up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available