The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorSamsung Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Histologically or cytologically confirmed Small cell lung cancers
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
No treatment is included in this protocol.
Other interventionTumor 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.
Treatment groups
797 Participants
are divided into 1 treatment groupGroup A: Small cell lung cancers1 intervention
Trial outcomes
Primary outcomes
1
Ratio of each molecular subtypes
To provide molecular characteristics of SCLC to proceed SUKSES trial
Time frame
After registration of this studySecondary outcomes
1
Success rate of each molecular profiling methods
To provide molecular characteristics of SCLC to proceed SUKSES trial
Time frame
After completion of registrationSponsors and contacts
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Source ClinicalTrials.gov