A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04452877
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    Dabrafenib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Dabrafenib will be administered orally twice daily (150 mg BID) for Days 1-21 of a 21-day cycle.
  • Trametinib — DRUG
    Trametinib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Trametinib will be administered orally once daily (2 mg QD) for Days 1-21 of a 21-day cycle

Study Details

This was a single-arm, open label, multicenter phase II, study of dabrafenib in combination with trametinib in Chinese participants with BRAF V600E mutation positive, stage IV NSCLC (American joint committee on cancer staging 8th edition). Approximately 40 Chinese adults were to be enrolled in this study. Participants were to be treated with dabrafenib in combination with trametinib until disease progression, start of a new anti-neoplastic therapy, unacceptable toxicity, pregnancy, withdrawal of consent, lost to follow-up, physician's decision, death, or if study be terminated by the sponsor. The general study design was discussed and agreed with China National Medical Products Administration and was based on a similar design used in the global pivotal phase II study (Study 113928 / NCT01336634).

Key Dates

Start date
Aug 19, 2020
Status verified
Dec 2025
Primary completion
Nov 7, 2024
Completion
Nov 7, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dabrafenib in combination with trametinib
    Dabrafenib 150 mg twice daily, trametinib 2 mg once daily

Primary Outcome Measure

Overall Response Rate (ORR), Central Independent Review Assessed by RECIST v1.1 [ Time Frame: From baseline until disease progression, death, lost to follow-up or withdrawal of consent, whichever occurs first, assessed up to approximately 50 months from treatment initiation ]

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