Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitor | Drug | — | UNRESOLVED |
| Platinum Doublet | Drug | Platinum Doublet | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Induction immunochemotherapy
- interventionNames
- Drug: PD-1 inhibitor
- Drug: Platinum Doublet
Primary outcomes (1)
- measure
- MPR
- timeFrame
- From date of enrollment until one month after resection
- description
- MPR is defined as ≤10% residual viable tumor in the resected specimen
Secondary outcomes (3)
- measure
- R0 resection rate
- timeFrame
- From date of enrollment to an average of 18 weeks after the first dose
- description
- defined as the percentage of patients that undergo R0 surgical resection after neoadjuvant treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available