Status:
RECRUITING
PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the clinical value of ctDNA testing in guiding the optimization of immunochemotherapy cycles during induction treatment for resectable patients with NSCL...
Detailed Description
Advances in precision medicine have highlighted the potential of circulating tumor DNA (ctDNA) detection in NSCLC diagnosis, treatment efficacy monitoring, and prognosis evaluation. Induction immunoth...
Eligibility Criteria
Inclusion
- Histologically/cytologically confirmed, untreated stage IIA-IIIB NSCLC (IASLC 8th edition).
- Deemed resectable by MDT.
- EGFR/ALK wild-type (non-squamous patients; squamous patients exempt).
- ECOG PS 0-1.
- Adequate organ function (neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, Hb \>9 g/dL, Cr ≤1.5×ULN, AST/ALT ≤3×ULN).
- Measurable lesions (RECIST 1.1).
Exclusion
- Active autoimmune diseases (exceptions: vitiligo, type I diabetes, stable hypothyroidism).
- Systemic corticosteroids (\>10 mg prednisone equivalent/day) within 14 days.
- Grade 3-4 interstitial lung disease.
- Concurrent malignancies requiring treatment.
- Prior anti-PD-1/PD-L1/CTLA-4 therapy.
- Active HBV/HCV, HIV/AIDS, or pregnancy.
Key Trial Info
Start Date :
May 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 10 2030
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT06977074
Start Date
May 10 2025
End Date
May 10 2030
Last Update
May 23 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060