RecruitingPhase 2NCT06977074

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


Sponsor

Sun Yat-sen University

Enrollment

83 participants

Start Date

May 10, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using a blood-based tool called ctDNA (circulating tumor DNA — tiny fragments of cancer DNA found in the blood) to guide personalized treatment decisions for people with early-stage lung cancer before surgery. The goal is to tailor how much immunotherapy and chemotherapy each person receives based on how their cancer is responding. **You may be eligible if...** - You have been diagnosed with non-small cell lung cancer (NSCLC) at stage IIA to IIIB - Your cancer has been assessed as surgically removable by a medical team - Your cancer does not carry EGFR or ALK mutations (unless it is squamous cell type) - You are in good overall health (ECOG 0 to 1) - You have not yet received any treatment for this lung cancer **You may NOT be eligible if...** - You have an active autoimmune disease requiring treatment - You are taking high-dose steroids - You have severe lung disease (Grade 3-4 interstitial lung disease) - You have previously received immunotherapy (PD-1, PD-L1, or CTLA-4 blockers) - You have active hepatitis B or C, or HIV - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-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

DRUGPlatinum 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

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NCT06977074


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