Clinical trial · Observational
Exploratory Biomarker Analysis of Neoadjuvant Chemoimmunotherapy Followed by Pulmonary Resection in Stage II-III Non-Small Cell Lung Cancer
A Prospective Cohort Study to Explore Biomarkers for Response to Neoadjuvant Chemoimmunotherapy in Stage II-III Non-small Cell Lung Cancer
NCT06907160CI-TRIAL-00088026recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
1. To explore tissue-based biomarkers to select patients who do not respond to neoadjuvant immunotherapy (non-responders) at the point of diagnosis 2. To explore blood-based non-invasive biomarkers to predict pathological complete response (pCR) before surgery
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clinical Stage II to III Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Neoadjuvant Immunotherapy
- description
- Establishment of a neoadjuvant ICI treatment cohort for resectable stage II-III lung cancer patients and acquisition of clinical-pathological-radiological data
Primary outcomes (1)
- 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.
- timeFrame
- Within the first 30 days (plus or minus 3 days) after surgery
- description
- 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.
Secondary outcomes (1)
- measure
- Progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven clinical stage II-III lung cancer patients * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.