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

Samsung Medical Center797 enrolled

Overview

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.

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

797

Conditions

Small Cell Lung Cancers Neuroendocrine Carcinoma

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (6)

Gachon University Gil Medical Center

Incheon, South Korea

COMPLETED

Seoul National University Bundang Hospital

Seongnam, South Korea

COMPLETED

Samsung Medical Center

Seoul, South Korea

RECRUITING

VHS Medical Center

Seoul, South Korea

COMPLETED

Chungbuk University Hospital

Taebuk, South Korea

COMPLETED

Ulsan University Hospital

Ulsan, South Korea

COMPLETED

Outcomes

Primary Outcomes

Ratio of each molecular subtypes

To provide molecular characteristics of SCLC to proceed SUKSES trial

Time frame: After registration of this study

Secondary Outcomes

Success rate of each molecular profiling methods

To provide molecular characteristics of SCLC to proceed SUKSES trial

Time frame: After completion of registration

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts