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 — DRUG
    Dabrafenib 150mg BID + Trametinib 2mg QD/(2 cycles)
  • Capmatinib — DRUG
    Capmatinib 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 mutation
    Dabrafenib + Trametinib
  • Experimental: Cohort 2: MET ex14 skip mutation
    Capmatinib

Primary Outcome Measure

Pathological complete response (pCR) rate [ Time Frame: up to 2 years ]

Central Contacts

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