Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
- Sponsor
- Sun Yat-sen University
- Study ID
- NCT06054191
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- BRAF V600 Mutation
- MET Exon 14 Mutation
- NSCLC
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Dabrafenib + Trametinib — DRUGDabrafenib 150mg BID + Trametinib 2mg QD/(2 cycles)
- Capmatinib — DRUGCapmatinib 400mg BID/(2 cycles)
Study Details
This is a Phase II, two parallel group study assessing the efficacy and safety of neoadjuvant and adjuvant targeted therapy in patients with stage IB-IIIA NSCLC harboring BRAF V600 or MET exon14 mutations.
Key Dates
- Start date
- Feb 1, 2024
- Status verified
- Oct 2023
- Primary completion
- Mar 1, 2025
- Completion
- Mar 1, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1: BRAF V600 mutationDabrafenib + Trametinib
- Experimental: Cohort 2: MET ex14 skip mutationCapmatinib
Primary Outcome Measure
Pathological complete response (pCR) rate [ Time Frame: up to 2 years ]
Central Contacts
- Li Zhang, MD86-20-87343458
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