NCT06977074 PROPHET Study: ctDNA-Guided Personalized Induction Immunochemotherapy for NSCLC
| NCT ID | NCT06977074 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sun Yat-sen University |
| Condition | Non-small Cell Lung Cancer (NSCLC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 83 participants |
| Start Date | 2025-05-10 |
| Primary Completion | 2028-05-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 83 participants in total. It began in 2025-05-10 with a primary completion date of 2028-05-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Ting Zhou
STUDY CHAIR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT06977074 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Non-small Cell Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06977074 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06977074 currently recruiting?
Yes, NCT06977074 is actively recruiting participants. Contact the research team at zhaozr@sysucc.org.cn for enrollment information.
Where is the NCT06977074 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06977074 clinical trial?
NCT06977074 is sponsored by Sun Yat-sen University. The principal investigator is Ting Zhou at Sun Yat-Sen University Cancer Center. The trial plans to enroll 83 participants.
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