Personalized immunochemotherapy for lung cancer using ctDNA guidance
Prospective Phase II Proof-of-Concept Trial on Circulating Tumor DNA (ctDNA)-Optimized Induction Immunochemotherapy Cycle Reduction for Resectable Non-Small Cell Lung Cancer
This study is testing if using blood tests to check for cancer DNA can help doctors give better and safer treatment cycles to patients with operable non-small cell lung cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 83 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | prednisone, chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06977074 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with untreated stage IIA-IIIB NSCLC who are deemed resectable and have specific genetic profiles.
Not a fit: Patients with active autoimmune diseases, concurrent malignancies, or those who have previously received certain immunotherapy treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment plans, reducing unnecessary cycles of therapy and associated side effects for patients.
How similar studies have performed: Other studies have shown promise in using ctDNA for treatment guidance, but this specific approach is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.