Personalized immunochemotherapy for lung cancer using ctDNA guidance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of using circulating tumor DNA (ctDNA) testing to optimize immunochemotherapy cycles for patients with resectable non-small cell lung cancer (NSCLC). It aims to determine if ctDNA clearance can indicate a complete pathological response and whether patients can avoid unnecessary treatment cycles. Approximately 83 patients will receive initial cycles of PD-1 inhibitor combined with platinum-based chemotherapy, with subsequent cycles guided by ctDNA status. The trial seeks to enhance treatment efficacy while minimizing toxicity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Ze-Rui Zhao, MD PhD
• Email: zhaozr@sysucc.org.cn
• Phone: +86 87343317

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.