Lung CancerLC_BiomarkerNCT03578185
Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy
An observational study of Lung Cancer, run by Samsung Medical Center at 3 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 2,000 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 11 Apr 2018to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- aged above or equal to 18
- Histologically confirmed lung cancer patients
- Patient treated with immune checkpoint inhibitor
- Exculsion Criteria:
- NA
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu
Se-hoon Lee, MD, 70-7014-4158 ext. 82, sehoon.lee119@gmail.com
Jinhee Seo, RN, 70-7014-4158 ext. 82, rufina.seo@samsung.com
- Recruiting
Seoul National University Hospital
Seoul, Joungro-gu
Tae-min Kim, MD, 2-2072-3559 ext. 82, gabriel9@snu.ac.kr
So-yun Kim, MD, thdus81@hanmail.net
- Not yet recruiting
Asan Medical Center
Seoul, Songpa-gu
Dae-ho Lee, MD, 2-3010-5925 ext. 82, leedaeho@amc.seoul.kr
Da-yi Joung, 2-3010-5925 ext. 2, joungdayi@naver.com
About this study
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.
Read the 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
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start11 Apr 2018
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Hoon Lee, Samsung Medical Center
- Investigators
- Se-hoon Lee, MD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578185
- Sponsor's protocol ID
- Lung cancer Biomarker_2018
- Acronym
- LC_Biomarker
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2018
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22042955Brahmer 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.
PubMed 22658128Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239.
PubMed 22437870Brahmer 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.
PubMed 20516446Patnaik 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.
PubMed 25977344
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Analysis to Identify a Predictive Biomarker for Immunotherapy
- ClinicalTrials.gov ID
- NCT03578185
- Acronym / sponsor ID
- LC_Biomarker / Lung cancer Biomarker_2018
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- aged above or equal to 18
- Histologically confirmed lung cancer patients
- Patient treated with immune checkpoint inhibitor
- NA
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
List of biomarkers
Time frame: Baseline
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 22042955Topalian 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.
- Background: PubMed 22658128Brahmer 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.
- Background: PubMed 22437870Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239.
- Background: PubMed 20516446Brahmer 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.
- Background: PubMed 25977344Patnaik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Se-hoon Lee, MD study chair
Samsung Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Samsung Medical Center at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Se-hoon Lee, MD (+82-10-4759-7640, sehoon.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
List of biomarkers (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578185, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.