PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC
Recruiting · NCT06977074 · Interventional (participants receive a specific treatment) · Lead sponsor: Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
PD-1 inhibitorPlatinum Doublet
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
1 location listed.
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China