Resectable Clinical Stage IB to III NSCLCNCT06907160
Prospective Observational Study of Baseline Tumor Genomic Profiling and Circulating Tumor DNA in Neoadjuvant Chemoimmunotherapy for Stage IB-III Non-Small Cell Lung Cancer
An observational study of Resectable Clinical Stage IB to III NSCLC, run by Yonsei University at 1 site in South Korea.
Trial summary
The goal of this observational study is to learn whether tests on tumor tissue and blood can predict how well patients with stage IB-III non-small cell lung cancer respond to chemotherapy combined with immunotherapy given before surgery (neoadjuvant chemoimmunotherapy). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Resectable Clinical Stage IB to III NSCLC
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2022to 31 Dec 2029
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who visited the Severance Hospital Lung Cancer Center Outpatient Clinic (Thoracic Surgery and Hematology Oncology) where the research team is affiliated will be registered after reviewing whether they meet the above selection/exclusion criteria by a researcher assigned by the research director.
Who may be able to join
- Histologically proven clinical stage IB-III non-small cell lung cancer
- No driver mutations (EGFR mutation and ALK alteration)
- Whole body performance (ECOG) 0-1
- Those over 19 years of age
- Subject who submitted Informed consent form
Who cannot join
- Under 19 years of age
- If there is a history of causing infection or other serious medical problems that impair the patient's function and make it difficult to comply with the study protocol.
- Patients for whom the investigator determines that the patient should not participate in the clinical trial because the patient is judged to be unable to comply with the clinical trial procedures and requirements (a person lacking medical capacity)
- Other patients (pregnant women, etc.) determined by the clinical trial director to be unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department of Thoracic and Cardiovascular Surgery, Severance Hospital, Yonsei University College of Medicine
Seoul
Tae Hee Hong, (82)10-3487-6255, thhongcs@yuhs.ac
About this study
Official title: A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage IB-III Non-Small Cell Lung Cancer
The goal of this observational study is to learn whether tests on tumor tissue and blood can predict how well patients with stage IB-III non-small cell lung cancer respond to chemotherapy combined with immunotherapy given before surgery (neoadjuvant chemoimmunotherapy).
The main questions it aims to answer are:
Read more
- Can tissue-based biomarkers, including genomic profiling of the tumor before treatment, identify at the time of diagnosis patients who are unlikely or likely to respond to neoadjuvant chemoimmunotherapy?
- Can blood-based, non-invasive biomarkers, such as circulating tumor DNA, predict pathologic complete response (no remaining cancer cells in the surgical specimen) before surgery?
Participants will receive neoadjuvant chemoimmunotherapy and surgery as part of their usual care. Tumor tissue obtained at diagnosis will be analyzed by genomic profiling, and blood samples will be collected at several time points, including before and during neoadjuvant treatment, before surgery, and during follow-up after surgery. Treatment will not be changed by this study.
Researchers will compare these test results with the response observed in the surgical specimen and with long-term outcomes such as cancer recurrence.
Read the detailed description
- Cohort construction: A prospective observational cohort of patients with resectable stage IB-III non-small cell lung cancer scheduled to receive neoadjuvant chemoimmunotherapy followed by curative-intent surgery will be established. Clinical, pathological, and radiological data will be collected prospectively, including radiologic response during neoadjuvant treatment and pathologic response (major pathologic response and pathologic complete response) in the resected specimen.
- Tissue-based biomarkers: Pretreatment tumor tissue obtained at diagnosis will undergo comprehensive genomic profiling using a targeted next-generation sequencing panel to identify actionable genomic alterations, copy-number alterations (including PD-L1/CD274), and other genomic features potentially associated with response or resistance to neoadjuvant chemoimmunotherapy. These findings will be evaluated together with routine biomarkers, including PD-L1 immunohistochemistry.
- Blood-based biomarkers: Plasma will be collected serially from individual patients at multiple time points, including before neoadjuvant treatment, during neoadjuvant treatment (e.g., after 2 cycles), before surgery, and during postoperative follow-up. Circulating tumor DNA (ctDNA) analysis will be performed to evaluate (a) on-treatment ctDNA dynamics as a non-invasive predictor of pathologic response before surgery and (b) postoperative ctDNA as a marker of molecular residual disease and recurrence risk.
- Study conduct: This is a non-interventional study. All patients will receive treatment according to standard clinical practice, and study-related test results will not be used to modify treatment. Tissue and blood biomarkers will be correlated with pathologic response and with long-term outcomes, including event-free survival.
- Keywords
- NSCLC, Neoadjuvant chemoimmunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemoimmunotherapy | Patients with resectable clincial stage IB-III non-small cell lung cancer scheduled to receive neoadjuvant chemoimmunotherapy followed by curative-intent surgery as part of standard care. Clinical, pathological, and radiological data are collected prospectively; pretreatment tumor tissue undergoes comprehensive genomic profiling, and plasma is collected serially for circulating tumor DNA analysis. No study-specific intervention is administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic response after surgery, assessed according to IASLC pathologic response criteria, including major pathologic response and pathologic complete response in resected specimens following neoadjuvant CIT.
Pathologic response after surgery will be assessed according to the IASLC pathologic response criteria in resected tumor specimens following neoadjuvant CIT.
Pathologic Complete Response (pCR): No residual viable tumor cells (0% viable tumor).
Major Pathologic Response (MPR): ≤10% residual viable tumor cells. Evaluation Method: Pathologic response will be determined by histopathological examination of the resected tumor tissue, with tumor regression grading based on hematoxylin and eosin (H\&E) staining.
Measured: Within the first 30 days (plus or minus 3 days) after surgery
Secondary outcomes (1)
Progression-free survival
Defined as time from initiation of neoadjuvant therapy to first disease recurrence or death (whichever occurred first), assessed up to 36 months.
Recurrence was defined as a diagnosis of metastatic disease, new locoregional disease, or any additional treatments for NSCLC after a 90-day treatment-free interval (to indicate the end of primary treatment and serve as a proxy for disease-free state postsurgery) starting right after initial surgery.
Measured: Defined as time from initiation of neoadjuvant therapy to first disease recurrence or death (whichever occurred first), assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Clinical Stage IB to III NSCLCStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Hee Hong, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907160
- Sponsor's protocol ID
- 4-2024-0434
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage IB-III Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06907160
- Acronym / sponsor ID
- 4-2024-0434
- Keywords
- NSCLC, Neoadjuvant chemoimmunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Apr 2025 (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.
The goal of this observational study is to learn whether tests on tumor tissue and blood can predict how well patients with stage IB-III non-small cell lung cancer respond to chemotherapy combined with immunotherapy given before surgery (neoadjuvant chemoimmunotherapy).
The main questions it aims to answer are:
- Can tissue-based biomarkers, including genomic profiling of the tumor before treatment, identify at the time of diagnosis patients who are unlikely or likely to respond to neoadjuvant chemoimmunotherapy?
- Can blood-based, non-invasive biomarkers, such as circulating tumor DNA, predict pathologic complete response (no remaining cancer cells in the surgical specimen) before surgery?
Participants will receive neoadjuvant chemoimmunotherapy and surgery as part of their usual care. Tumor tissue obtained at diagnosis will be analyzed by genomic profiling, and blood samples will be collected at several time points, including before and during neoadjuvant treatment, before surgery, and during follow-up after surgery. Treatment will not be changed by this study.
Researchers will compare these test results with the response observed in the surgical specimen and with long-term outcomes such as cancer recurrence.
Detailed description
- Cohort construction: A prospective observational cohort of patients with resectable stage IB-III non-small cell lung cancer scheduled to receive neoadjuvant chemoimmunotherapy followed by curative-intent surgery will be established. Clinical, pathological, and radiological data will be collected prospectively, including radiologic response during neoadjuvant treatment and pathologic response (major pathologic response and pathologic complete response) in the resected specimen.
- Tissue-based biomarkers: Pretreatment tumor tissue obtained at diagnosis will undergo comprehensive genomic profiling using a targeted next-generation sequencing panel to identify actionable genomic alterations, copy-number alterations (including PD-L1/CD274), and other genomic features potentially associated with response or resistance to neoadjuvant chemoimmunotherapy. These findings will be evaluated together with routine biomarkers, including PD-L1 immunohistochemistry.
- Blood-based biomarkers: Plasma will be collected serially from individual patients at multiple time points, including before neoadjuvant treatment, during neoadjuvant treatment (e.g., after 2 cycles), before surgery, and during postoperative follow-up. Circulating tumor DNA (ctDNA) analysis will be performed to evaluate (a) on-treatment ctDNA dynamics as a non-invasive predictor of pathologic response before surgery and (b) postoperative ctDNA as a marker of molecular residual disease and recurrence risk.
- Study conduct: This is a non-interventional study. All patients will receive treatment according to standard clinical practice, and study-related test results will not be used to modify treatment. Tissue and blood biomarkers will be correlated with pathologic response and with long-term outcomes, including event-free survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemoimmunotherapy | – | –Patients with resectable clincial stage IB-III non-small cell lung cancer scheduled to receive neoadjuvant chemoimmunotherapy followed by curative-intent surgery as part of standard care. Clinical, pathological, and radiological data are collected prospectively; pretreatment tumor tissue undergoes comprehensive genomic profiling, and plasma is collected serially for circulating tumor DNA analysis. No study-specific intervention is administered. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who visited the Severance Hospital Lung Cancer Center Outpatient Clinic (Thoracic Surgery and Hematology Oncology) where the research team is affiliated will be registered after reviewing whether they meet the above selection/exclusion criteria by a researcher assigned by the research director.
Key inclusion criteria (5 listed)
- Histologically proven clinical stage IB-III non-small cell lung cancer
- No driver mutations (EGFR mutation and ALK alteration)
- Whole body performance (ECOG) 0-1
- Those over 19 years of age
- Subject who submitted Informed consent form
Key exclusion criteria (4 listed)
- Under 19 years of age
- If there is a history of causing infection or other serious medical problems that impair the patient's function and make it difficult to comply with the study protocol.
- Patients for whom the investigator determines that the patient should not participate in the clinical trial because the patient is judged to be unable to comply with the clinical trial procedures and requirements (a person lacking medical capacity)
- Other patients (pregnant women, etc.) determined by the clinical trial director to be unsuitable for this clinical trial.
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
Pathologic response after surgery, assessed according to IASLC pathologic response criteria, including major pathologic response and pathologic complete response in resected specimens following neoadjuvant CIT.
Time frame: Within the first 30 days (plus or minus 3 days) after surgery
Pathologic response after surgery will be assessed according to the IASLC pathologic response criteria in resected tumor specimens following neoadjuvant CIT. Pathologic Complete Response (pCR): No residual viable tumor cells (0% viable tumor). Major Pathologic Response (MPR): ≤10% residual viable tumor cells. Evaluation Method: Pathologic response will be determined by histopathological examination of the resected tumor tissue, with tumor regression grading based on hematoxylin and eosin (H\&E) staining.
1 secondary outcome
Progression-free survival
Time frame: Defined as time from initiation of neoadjuvant therapy to first disease recurrence or death (whichever occurred first), assessed up to 36 months
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Clinical Stage IB to III NSCLC, run by Yonsei University at 1 site 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 4 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 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Tae Hee Hong, MD, PhD ((82)10-3487-6255, thhongcs@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic response after surgery, assessed according to IASLC pathologic response criteria, including major pathologic response and pathologic complete response in resected specimens following neoadjuvant CIT. (time frame: Within the first 30 days (plus or minus 3 days) after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.