Clinical trial · Observational
ctDNA-MRD in Stage IIIB-C NSCLC Patients Treated With Induction Chemoimmunotherapy
The Role of Dynamic Circulating Tumor DNA-Molecular Residual Disease (ctDNA-MRD) Testing in Stage IIIB-C Oncogene-negative NSCLC Patients Treated With Induction Chemoimmunotherapy in the Multidisciplinary Team (MDT) Model of Diagnosis and Treatment
- 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)
The goal of this observational study is to explore whether ctDNA-MRD dynamic monitoring can more effectively predict the therapeutic effect of induction chemoimmunotherapy followed by surgery or non-surgical treatment for stage IIIB-C driver-negative NSCLC in the MDT model, so as to accurately guide clinical diagnosis and treatment.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NGS and ctDNA-MRD detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with stage IIIB-C driver-negative NSCLC receiving induction chemoimmunotherapy
- interventionNames
- Diagnostic Test: NGS and ctDNA-MRD detection
Primary outcomes (3)
- measure
- Predicting Progression Free Survival
- timeFrame
- up to 5 years
- description
- Ability of dynamic ctDNA-MRD assessment to predict progression-free survival (PFS) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery or non-surgical therapy
- measure
- Predicting pathologic complete response
- timeFrame
- Up to 1 year
- description
- Ability of dynamic ctDNA-MRD assessment to predict pathologic complete response (pCR) in stage IIIB-C driver-negative NSCLC patients receiving induction chemoimmunotherapy followed by surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathology or cytology confirmed the non-small cell lung cancer * Age ranging from 18 to 75 * Agree to participate in this study and sign an informed consent form * Treatment-naive tumor * Driver gene negativity * According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage IIIB-C potentially resectable tumor * The Eastern Cooperative Oncology Group (ECOG) performance status (PS) score is 0-1 Exclusion Criteria: * Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form * Small cell lung cancer * Driver gene positivity * Tumor directly invades esophagus, heart, aorta, diaphragm, trachea, or carina, or is considered unresectable even following induction therapy * Patients with solid organ or blood system transplantation * Previous use of recombinant cytotoxic T-lymphocyte associated antigen 4 (CTLA-4), programmed cell death 1 (PD-1), or programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitors * Patients with interstitial lung disease * Patients with acute or chronic infectious disease * Pregnant and lactating women * Patients who have undergone other clinical drug trials
References
Publications (0)
Data not yet available