Small Cell Lung CancersNCT02688894
The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
An observational study of Small Cell Lung Cancers and Neuroendocrine Carcinoma, run by Samsung Medical Center at 6 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Small Cell Lung Cancers, Neuroendocrine Carcinoma
- What is being tested?
- No treatment is included in this protocol.
- How many people
- 797 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 10 Jun 2016to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Histologically or cytologically confirmed Small cell lung cancers
Who may be able to join
- Provision of fully informed consent prior to any study specific procedures.
- Patients must be ≥20 years of age.
- Histologically or cytologically confirmed Small cell lung cancers
- ECOG performance status of 0 to 2
- Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment
- Patients with available archival tissues for molecular analysis or patients who agreed with biopsy for molecular analysis
Who cannot join
- More than two prior chemotherapy regimen for the treatment of small cell lung cancer
- Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 1 recruiting
- Completed
Gachon University Gil Medical Center
Incheon
- Completed
Chungbuk University Hospital
Jungbuk
- Completed
Seoul National University Bundang Hospital
Seongnam
- Recruiting
Samsung Medical Center
Seoul, 135-710
Se-Hoon Lee, M.D., Ph.D., 82-2-2148-7665, sehoon.lee@samsung.com
Se-Hoon Lee
- Completed
VHS Medical Center
Seoul
- Completed
Ulsan University Hospital
Ulsan
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Small Cell Lung Cancers, Neuroendocrine Carcinoma
- Being tested
- No treatment is included in this protocol.
- Medical subject headings
- Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No treatment is included in this protocol.Other
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No treatment is included in this protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of each molecular subtypes
To provide molecular characteristics of SCLC to proceed SUKSES trial
Measured: After registration of this study
Secondary outcomes (1)
Success rate of each molecular profiling methods
To provide molecular characteristics of SCLC to proceed SUKSES trial
Measured: After completion of registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start10 Jun 2016
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancersStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 797 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Hoon Lee, Samsung Medical Center
- Investigators
- Se-Hoon Lee, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688894
- Sponsor's protocol ID
- 2016-02-071
- Status last verified
- Aug 2026
- First submitted
- 18 Feb 2016
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
- ClinicalTrials.gov ID
- NCT02688894
- Acronym / sponsor ID
- 2016-02-071
- Conditions
- Small Cell Lung Cancers, Neuroendocrine Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 797 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Small cell lung cancers | – | Other: No treatment is included in this protocol.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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically confirmed Small cell lung cancers
Key inclusion criteria (6 listed)
- Provision of fully informed consent prior to any study specific procedures.
- Patients must be ≥20 years of age.
- Histologically or cytologically confirmed Small cell lung cancers
- ECOG performance status of 0 to 2
- Patients who are being treated or were treated with platinum-based chemotherapy as a first-line treatment
Key exclusion criteria (3 listed)
- More than two prior chemotherapy regimen for the treatment of small cell lung cancer
- Pregnant or nursing women (women of reproductive potential have to agree to use an effective contraceptive method)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Small cell lung cancers |
Primary outcome
Ratio of each molecular subtypes
Time frame: After registration of this study
To provide molecular characteristics of SCLC to proceed SUKSES trial
1 secondary outcome
Success rate of each molecular profiling methods
Time frame: After completion of registration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Se-Hoon Lee, MD, PhD principal investigator
Samsung Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancers and Neuroendocrine Carcinoma, run by Samsung Medical Center at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Se-Hoon Lee, MD,Ph.D. (+82-10-4759-7640, sehoon.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of each molecular subtypes (time frame: After registration of this study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.