NCT06977074RecruitingPhase 2
PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC
Prospective Phase II Proof-of-Concept Trial on Circulating Tumor DNA (ctDNA)-Optimized Induction Immunochemotherapy Cycle Reduction for Resectable Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 23 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 83 (estimated)
- First submitted
- 1 May 2025
- Start date
- May 2025
- Primary completion date
- May 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Lung cancer
- NCT number
- NCT06977074
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 83
- From May 2025 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Systemic corticosteroids (\>10 mg prednisone equivalent/day) within 14 days.
- Concurrent malignancies requiring treatment.
- Prior anti-PD-1/PD-L1/CTLA-4 therapy.
Other illness
- Active autoimmune diseases (exceptions: vitiligo, type I diabetes, stable hypothyroidism).
- Grade 3-4 interstitial lung disease.
- Active HBV/HCV, HIV/AIDS, or pregnancy.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.