Neuroendocrine Carcinoma / No treatment is included in this protocol. / Small Cell Lung Cancers · Observational Study

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

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an active molecular screening study in relapsed small cell lung cancer that aims to characterize tumor molecular subtypes using NGS, immunohistochemistry, and FISH to stratify patients for future intervention trials. No results are reported in this registry record.

What was studied

Observational. Small Cell Lung Cancers, Neuroendocrine Carcinoma; age from 20 Years. Intervention: Small cell lung cancers. n = 797. 6 sites: South Korea.

Key findings

Safety

Primary endpoint is descriptive (molecular subtype ratios); no clinical efficacy or safety outcomes are measured in this screening protocol.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record for an ongoing molecular screening study with no reported results; it describes planned enrollment and methodology only, making it a feasibility and characterization effort preceding intervention trials.

Study design

As stated by the source record.

MethodsOther model. Prospective time perspective. Primary outcome measure: Ratio of each molecular subtypes (assessed at After registration of this study)

DesignObservational

PopulationSmall Cell Lung Cancers, Neuroendocrine Carcinoma; age from 20 Years

Sample size797

InterventionSmall cell lung cancers

Setting6 sites: South Korea

Reported figures

Quoted from the source exactly as published.

Estimated enrollment797

Primary outcome measureRatio of each molecular subtypes

Caveats

This is a registry record only; no outcome data or molecular subtype results are reported.
Study is actively recruiting; follow-up required for completed molecular characterization.
Primary endpoint is descriptive (molecular subtype ratios); no clinical efficacy or safety outcomes are measured in this screening protocol.
No intervention or comparator is included; this study feeds eligibility data to separate SUKSES trial intervention arms.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational, non-interventional molecular profiling protocol with defined testing panel.

Directness

limited

Screening study generates biomarker data to inform eligibility for separate intervention trials.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record.

Risk of bias

insufficient

Registry record does not report results or analyze outcomes; bias assessment not applicable.

Sample adequacy

moderate

Estimated enrollment 797 participants; adequate for molecular subtype characterization.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT02688894). This is a study registration, not published results. Lead sponsor: Samsung Medical Center. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 797 participants (ESTIMATED). Conditions: Small Cell Lung Cancers, Neuroendocrine Carcinoma. Interventions: OTHER: No treatment is included in this protocol.. Primary outcome measures: Ratio of each molecular subtypes , After registration of this study. Brief 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Samsung Medical CenterNeuroendocrine CarcinomaNo treatment is included in this protocol.Small Cell Lung CancersNCT02688894