Clinical trial NCT02688894: The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
Official title: The Molecular Screening Study for the Umbrella Trial (SUKSES) in Relapsed Small Cell Lung Cancer Patients [SUKSES-S]
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Small Cell Lung Cancers
Neuroendocrine Carcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 797
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Histologically or cytologically confirmed Small cell lung cancers

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.

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.

Eligibility 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.

Primary outcomes:
measure: Ratio of each molecular subtypes
timeFrame: After registration of this study
Secondary outcomes:
measure: Success rate of each molecular profiling methods
timeFrame: After completion of registration
Other outcomes:
Locations:
city: Chungbuk
country: Korea, Republic of
facility: Chungbuk University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Samsung Medical Center
name: Se-Hoon Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: