PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC

Condition(s) studied

Investigational drug(s) / intervention(s)

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 \[squamous/other subtypes\])

Study 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

Primary outcome measure(s)

• MPR — From date of enrollment until one month after resection
  MPR is defined as ≤10% residual viable tumor in the resected specimen

Trial sites (1)

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