Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

Lung Cancer Clinical Trial

— LC_Biomarker  

Official title:

Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578185
• Other study ID #: Lung cancer Biomarker_2018
• Status: Recruiting
• Start date: April 11, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: Se-hoon Lee, MD
• Phone: +82-10-4759-7640
• Email: sehoon.lee[@]samsung.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is designed to identify the predictive biomarker for immunotherapy using patient samples (tumor tissue, blood, fecal material) who treated with immune checkpoint inhibitor.

Description:

[Sample acquisition]

• Informed consent is waived for those who agree to donate samples left over from other clinical trials or acquired for other purposes to be used for other research by the sign to master agreement in advance.

• The study will be conducted based on the purposes indicated in the master agreement signed by tissue donator [Clinical data acquisition]

• Baseline demographics: Sex, Birth date, expire date (last follow-up date for the survivals)

• Lung cancer treatment history: diagnosed date, treatment history (surgery, radiation therapy, chemotherapy, immunotherapy treatment history, and responses), general performance, metastatic sites

• Lung cancer histologic information: pathology, histologic subtype, EGFR mutation profile, ALK-rearrangement result

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. aged above or equal to 18

2. Histologically confirmed lung cancer patients

3. Patient treated with immune checkpoint inhibitor

Exculsion Criteria:

NA

Related Conditions & MeSH terms

• Lung Cancer

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu
Korea, Republic of	Seoul National University Hospital	Seoul	Joungro-gu

Sponsors (1)

Lead Sponsor	Collaborator
Se-Hoon Lee

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

Brahmer JR, Drake CG, Wollner I, Powderly JD, Picus J, Sharfman WH, Stankevich E, Pons A, Salay TM, McMiller TL, Gilson MM, Wang C, Selby M, Taube JM, Anders R, Chen L, Korman AJ, Pardoll DM, Lowy I, Topalian SL. Phase I study of single-agent anti-programmed death-1 (MDX-1106) in refractory solid tumors: safety, clinical activity, pharmacodynamics, and immunologic correlates. J Clin Oncol. 2010 Jul 1;28(19):3167-75. doi: 10.1200/JCO.2009.26.7609. Epub 2010 Jun 1. — View Citation

Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2. — View Citation

Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239. Review. — View Citation

Patnaik A, Kang SP, Rasco D, Papadopoulos KP, Elassaiss-Schaap J, Beeram M, Drengler R, Chen C, Smith L, Espino G, Gergich K, Delgado L, Daud A, Lindia JA, Li XN, Pierce RH, Yearley JH, Wu D, Laterza O, Lehnert M, Iannone R, Tolcher AW. Phase I Study of Pembrolizumab (MK-3475; Anti-PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors. Clin Cancer Res. 2015 Oct 1;21(19):4286-93. doi: 10.1158/1078-0432.CCR-14-2607. Epub 2015 May 14. — View Citation

Topalian SL, Weiner GJ, Pardoll DM. Cancer immunotherapy comes of age. J Clin Oncol. 2011 Dec 20;29(36):4828-36. doi: 10.1200/JCO.2011.38.0899. Epub 2011 Oct 31. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	List of biomarkers	Neoantigen, tumor mutation burden, MHC compatibility, T-cell receptor and associated immune gene signature (IFN-r, interferons such as IL-2 and interleukin family), T-cell subset (T cell surface marker such as CD4+, CD7+, CD8+, CD16, CD34+, CD38+, CD56+, etc.), PD-1/PD-L1 expression, etc.	Baseline