Prospective Phase II Proof-of-Concept Trial on Circulating Tumor DNA (ctDNA)-Optimized Induction Immunochemotherapy Cycle Reduction for Resectable Non-Small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Ze-Rui Zhao, MD PhD
zhaozr@sysucc.org.cn
+86 87343317
Time Frame
Start Date: 2025-05-10
Estimated Completion Date: 2030-05-10
Participants
Target number of participants: 83
Treatments
Experimental: Induction immunochemotherapy
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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