NCT03578185

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

2.7 years

First QC Date

June 25, 2018

Last Update Submit

November 29, 2024

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Total of 800 lung cancer patients treated with immune checkpoint inhibitor Study will be initiated from the date of IRB approval to Dec. 2020 for those who signed for master agreement for tissue donation for research purposes.

You may qualify if:

  • aged above or equal to 18
  • Histologically confirmed lung cancer patients
  • Patient treated with immune checkpoint inhibitor
  • Exculsion Criteria:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Joungro-gu, South Korea

RECRUITING

Asan Medical Center

Seoul, Songpa-gu, South Korea

NOT YET RECRUITING

Related Publications (5)

  • 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.

    PMID: 22042955BACKGROUND

  • 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.

    PMID: 22658128BACKGROUND

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

    PMID: 22437870BACKGROUND

  • 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.

    PMID: 20516446BACKGROUND

  • 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.

    PMID: 25977344BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The following analysis will be conducted using samples (tissue, blood, fecal material) form the patient who treated with immune checkpoint inhibitor

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Se-hoon Lee, MD

    Samsung Medical Center

    STUDY CHAIR

Central Study Contacts

Se-hoon Lee, MD

CONTACT

+82-10-4759-7640sehoon.lee@samsung.com

Jinhee Seo

CONTACT

+82-70-7014-4158rufina.seo@samsung.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 6, 2018

Study Start

April 11, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2025

Last Updated

December 3, 2024

Record last verified: 2024-11

Locations

KR(3)