PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC
Prospective Phase II Proof-of-Concept Trial on Circulating Tumor DNA (ctDNA)-Optimized Induction Immunochemotherapy Cycle Reduction for Resectable Non-Small Cell Lung Cancer
Sun Yat-sen University
83 participants
May 10, 2025
INTERVENTIONAL
Conditions
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 NSCLC. The main questions it aims to answer are: * Does ctDNA clearance indicate pathological complete response? * Are additional cycles of immunochemotherapy necessary for patients who have ctDNA clearance after initial cycles of treatment? Researchers will use ctDNA dynamics to guide the cycles of induction treatment to see if some patients can avoid excessive cycles of treatment.
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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.
Interventions
Two to four cycles of tislelizumab at a dose of 200 mg every three weeks, along with a platinum-based chemotherapy doublet based on the result of ctDNA dynamics
Platinum-based chemotherapy (carboplatin AUC=5 + pemetrexed 500 mg/m² \[adenocarcinoma\] or nab-paclitaxel 260 mg/m² \[squamous/other subtypes\])
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06977074