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Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03578185
Acronym
LC_Biomarker
Enrollment
2000
Registered
2018-07-06
Start date
2018-04-11
Completion date
2030-12-31
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Detailed 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

Interventions

None listed

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
List of biomarkersBaselineNeoantigen, 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.

Countries

South Korea

Contacts

CONTACTSe-hoon Lee, MD
sehoon.lee@samsung.com+82-10-4759-7640
CONTACTJinhee Seo
rufina.seo@samsung.com+82-70-7014-4158
STUDY_CHAIRSe-hoon Lee, MD

Samsung Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026