Actively Recruiting
PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC
Led by Sun Yat-sen University · Updated on 2025-05-23
83
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed untreated stage IIA to IIIB non-small cell lung cancer
- Tumor judged resectable by a multidisciplinary team
- EGFR/ALK wild-type for non-squamous patients (not required for squamous patients)
- ECOG performance status of 0 or 1
- Adequate organ function including neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin >9 g/dL, creatinine ≤1.5× upper limit of normal, AST/ALT ≤3× upper limit of normal
- Measurable lesions based on RECIST 1.1 criteria
You will not qualify if you...
- Active autoimmune diseases except vitiligo, type I diabetes, or stable hypothyroidism
- Use of systemic corticosteroids over 10 mg prednisone equivalent per day within 14 days
- Grade 3 or 4 interstitial lung disease
- Having other cancers requiring treatment at the same time
- Previous treatment with anti-PD-1, PD-L1, or CTLA-4 therapies
- Active hepatitis B or C virus, HIV/AIDS infection, or pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Z
Ze-Rui Zhao, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here