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PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC
Sponsor: Sun Yat-sen University
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.
Official title: Prospective Phase II Proof-of-Concept Trial on Circulating Tumor DNA (ctDNA)-Optimized Induction Immunochemotherapy Cycle Reduction for Resectable Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
83
Start Date
2025-05-10
Completion Date
2030-05-10
Last Updated
2025-05-23
Healthy Volunteers
No
Conditions
Interventions
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
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