Molecular screening for relapsed small cell lung cancer patients
The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
This study is testing a way to analyze the DNA from tissue and blood samples of patients with relapsed small cell lung cancer to see if it can help identify who might benefit from new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 797 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Incheon and 5 other locations) |
| Trial ID | NCT02688894 on ClinicalTrials.gov |
What this trial studies
This protocol focuses on molecular screening for patients with relapsed small cell lung cancer, utilizing DNA extracted from archived or fresh tissue and blood samples. The study employs next-generation sequencing (NGS) and Nanostring CNV testing, along with immunohistochemistry and FISH analysis, to profile the molecular characteristics of tumors. The molecular profiling can occur before, during, or after initial treatment, and aims to identify patients who may qualify for subsequent drug intervention studies based on their molecular profiles.
Who should consider this trial
Good fit: Ideal candidates include patients aged 20 and older with histologically or cytologically confirmed small cell lung cancer who have undergone platinum-based chemotherapy.
Not a fit: Patients with more than two prior chemotherapy regimens for small cell lung cancer or those with second primary cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify targeted treatment options for patients with relapsed small cell lung cancer.
How similar studies have performed: Other studies utilizing molecular profiling in cancer treatment have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of fully informed consent prior to any study specific procedures. 2. Patients must be ≥20 years of age. 3. Histologically or cytologically confirmed Small cell lung cancers 4. ECOG performance status of 0 to 2 5. Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment 6. Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis Exclusion Criteria: 1. More than two prior chemotherapy regimen for the treatment of small cell lung cancer 2. Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method) 3. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤2 years.
Where this trial is running
Incheon and 5 other locations
- Gachon University Gil Medical Center — Incheon, South Korea (Completed)
- Chungbuk University Hospital — Jungbuk, South Korea (Completed)
- Seoul National University Bundang Hospital — Seongnam, South Korea (Completed)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- VHS Medical Center — Seoul, South Korea (Completed)
- Ulsan University Hospital — Ulsan, South Korea (Completed)
Study contacts
- Principal investigator: Se-Hoon Lee, MD, PhD — Samsung Medical Center
- Study coordinator: Se-Hoon Lee, MD,Ph.D.
- Email: sehoon.lee@samsung.com
- Phone: +82-10-4759-7640
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.