Prospective Multiomic Analysis in Small-Cell Lung Cancer to Inform Therapeutic Vulnerabilities and Predict Clinical Outcomes: Deep Phenotyping of Relapsed SCLC Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of obtaining paired tumor samples and serial blood collection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Biospecimen collection (Procedure)
结局指标
主要结局
Feasibility of obtaining paired tumor samples and serial blood collection
时间窗: 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
次要结局
- Investigator-assessed objective response rate (ORR)(Up to 3 years)
- Progression-free survival (PFS(Up to 3 years)
- Overall survival (OS)(Up to 3 years)
研究者
Asrar Alahmadi
Principal Investigator
Ohio State University Comprehensive Cancer Center