Clinical trial · Interventional
The Feasibility of Dynamic Liquid Biopsy Monitoring During Neoadjuvant Treatment for EGFR-mutated NSCLC
NCT06287593CI-TRIAL-00076441not yet recruitingN/AClinicalTrials.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)
This study aimed to assess the value of dynamic ctDNA monitoring in guiding the development of personalized neoadjuvant treatment strategies for EGFR-mutated NSCLC patients.
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 |
|---|---|---|---|
| EGF-R Positive Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- group A
- description
- For patients with negative ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks.
- interventionNames
- Other: ctDNA monitoring
- type
- OTHER
- label
- group B
- description
- For patients with positive ctDNA after 3 weeks of neoadjuvant TKI treatment, radical resection surgery will be performed after continuing TKI treatment for 9-12 weeks.
- interventionNames
- Other: ctDNA monitoring
- type
- OTHER
- label
- group C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients should voluntarily join this study and sign the informed consent form 2. Patients diagnosed with resectable stage II-IIIB (T1-4N0-2M0, excluding T4 with invasion of vital structures and bulky or infiltrative N2) NSCLC 3. Patients with EGFR 19del or L858R mutations. 4. Age from 18 to 75 years old, both male and female 5. ECOG score 0-1 6. According to the RECIST v1.1 , patients should have at least one measurable lesion 7. For suspicious mediastinal lymph nodes (including pathological enlargement or PET-CT indicating malignancy, etc.), further sampling is required for pathological diagnosis by EUBS, thoracoscopy, or mediastinoscopy 8. According clinical evaluation, the lung function of patients (such as FVC, FEV1, TLC, FRC, DLco, etc.) should be sufficient for pneumonectomy 9. The function of important organs should meet the following requirements: absolute count of neutrophils ≥ 1.5 × 109/L# Platelets ≥ 100 × 109/L# Hemoglobin ≥ 90g/L; Serum albumin ≥ 35g/L; Thyroid hormone (TSH) ≤ 1 × ULN# Serum bilirubin ≤ 1.5 × ULN# ALT and AST ≤ 3 × ULN# International standardized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN# Serum creatinine ≤ 1.5 × ULN 10. Female patients at childbearing age are required to use contraceptive measures; for male patients whose partners are women at childbearing age, effective methods of contraception should be used during the trial period Exclusion Criteria: 1. Patients with other primary malignancies within the past 3 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ) 2. Patients with active hepatitis B/C 3. Patients with any active autoimmune diseases or a history of autoimmune diseases 4. Patients who are using immunosuppressive agents or require systemic hormone therapy 5. Patients with hypertension but without good control even through antihypertensive medication treatment ; patients with clinical symptoms or diseases related to unsatisfying cardiac function 6. Patients with abnormal coagulation function (INR\>2.0, PT\>16s) 7. Arterial/venous thrombotic events occurred before screening within 6 months 8. Patients with active infection 9. Patients with congenital or acquired immune dysfunction (such as HIV infection) 10. According to the judgment of the researchers, patients have other factors that may affect the results of the research or cause the research to be terminated
References
Publications (0)
Data not yet available
No reference posted for this study.