RECRUITINGPhase 2INTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Histologically/cytologically confirmed, untreated stage IIA-IIIB NSCLC (IASLC 8th edition). 2. Deemed resectable by MDT. 3. EGFR/ALK wild-type (non-squamous patients; squamous patients exempt). 4. ECOG PS 0-1. 5. your organs (liver, kidneys, etc.) are working well enough based on blood tests (neutrophils ≥1.5×10⁹/L, platelet count at least 100×10⁹/L, Hb \>9 g/dL, Cr ≤1.5×ULN, AST/ALT ≤3×ULN). 6. Measurable lesions (RECIST 1.1). Who Should NOT Join This Trial: 1. Active autoimmune conditions (where your immune system attacks your own body)s (exceptions: vitiligo, type I diabetes, stable hypothyroidism). 2. Systemic corticosteroids (\>10 mg prednisone equivalent/day) within 14 days. 3. Grade 3-4 interstitial lung disease. 4. Concurrent malignancies requiring treatment. 5. Prior anti-PD-1/PD-L1/CTLA-4 therapy. 6. Active HBV/HCV, HIV/AIDS, or pregnancy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Histologically/cytologically confirmed, untreated stage IIA-IIIB NSCLC (IASLC 8th edition). 2. Deemed resectable by MDT. 3. EGFR/ALK wild-type (non-squamous patients; squamous patients exempt). 4. ECOG PS 0-1. 5. Adequate organ function (neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, Hb \>9 g/dL, Cr ≤1.5×ULN, AST/ALT ≤3×ULN). 6. Measurable lesions (RECIST 1.1). Exclusion Criteria: 1. Active autoimmune diseases (exceptions: vitiligo, type I diabetes, stable hypothyroidism). 2. Systemic corticosteroids (\>10 mg prednisone equivalent/day) within 14 days. 3. Grade 3-4 interstitial lung disease. 4. Concurrent malignancies requiring treatment. 5. Prior anti-PD-1/PD-L1/CTLA-4 therapy. 6. Active HBV/HCV, HIV/AIDS, or pregnancy.

Treatments Being Tested

DRUG

PD-1 inhibitor

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

DRUG

Platinum Doublet

Platinum-based chemotherapy (carboplatin AUC=5 + pemetrexed 500 mg/m² \[adenocarcinoma\] or nab-paclitaxel 260 mg/m² \[squamous/other subtypes\])

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China