The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]

April 23, 2026 updated by: Se-Hoon Lee, Samsung Medical Center

This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial.

This procedure can be performed during or after the first-line treatment. DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood.

Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.

Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH.

Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This protocol is a molecular screening protocol only. No drug intervention study will be included in this protocol. Based on the molecular profiling, patients may be eligible for drug intervention study of SUKSES trial.

This procedure (molecular profiling) can be performed before, during, or after the initial treatment.

DNA will be extracted from the archived or fresh tissue and blood. NGS-based cancer panel and Nanostring CNV will be tested with DNA from tissue and/or blood.

Immunohistochemistry and FISH will be done by pathologists using archived or fresh tissue.

In addition, blood collection will be conducted at Baseline (initial), three weeks, six weeks, twelve weeks, and subsequent imaging.

Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH. Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.

Study Type

Observational

Enrollment (Estimated)

797

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Incheon, South Korea
        • Completed
        • Gachon University Gil Medical Center
      • Jungbuk, South Korea
        • Completed
        • Chungbuk University Hospital
      • Seongnam, South Korea
        • Completed
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 135-710
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Se-Hoon Lee
        • Contact:
      • Seoul, South Korea
        • Completed
        • VHS Medical Center
      • Ulsan, South Korea
        • Completed
        • Ulsan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Histologically or cytologically confirmed Small cell lung cancers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Small cell lung cancers
To provide molecular characteristics of Small cell lung cancers to proceed SUKSES trial, To assess success rate of molecular profiling of Small cell lung cancers
Other: No treatment is included in this protocol.

Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH.

Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of each molecular subtypes
Time Frame: After registration of this study
To provide molecular characteristics of SCLC to proceed SUKSES trial
After registration of this study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of each molecular profiling methods
Time Frame: After completion of registration
To provide molecular characteristics of SCLC to proceed SUKSES trial
After completion of registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Se-Hoon Lee, MD, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2016

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimated)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-02-071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuroendocrine Carcinoma

Clinical Trials on No treatment is included in this protocol.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Poland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe