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

Neuroendocrine Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02688894
• Other study ID #: 2016-02-071
• Status: Recruiting
• Start date: April 29, 2016
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Samsung Medical Center
• Contact: Se-Hoon Lee, MD,Ph.D.
• Phone: +82-10-4759-7640
• Email: sehoon.lee[@]samsung.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 797
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Lung Neoplasms
• Neuroendocrine Carcinoma
• Small Cell Lung Cancers
• Small Cell Lung Carcinoma

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk University Hospital	Chungbuk
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	VHS Medical Center	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of each molecular subtypes	To provide molecular characteristics of SCLC to proceed SUKSES trial	After registration of this study
Secondary	Success rate of each molecular profiling methods	To provide molecular characteristics of SCLC to proceed SUKSES trial	After completion of registration