BRF113928: A Phase II study of the BRAF inhibitor dabrafenib as a single agent and in combination with the MEK inhibitor trametinib in subjects with BRAF V600E mutation positive metastatic (stage IV) non-small cell lung cancer

Phase 2

Completed

• Conditions: non-small cell lung cancer; lung cancer; 10029107

• Registration Number: NL-OMON47910
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Histologically or cytologically confirmed NDCLC stage IV.
* Documented disease progression (primary study cohort). Subjects in Cohort C
will be
required to have not received prior systemic anti-cancer therapies for
metastatic disease
* Measurable disease.
* 18 years and above.
* Life expectancy at least 3 months.
* ECOG performance status 0-2.
* Presence of a V600E BRAF mutation in lung cancer tissue.
* Females of childbearing potential: adequate method of contraception.

Exclusion Criteria

* Previous treatment with a BRAF or MEK inhibitor.
* Anti-Cancer therapy including chemotherapy, radiation-therapy, immunotherapy,
biologic therapy or major surgery within 14 days prior to start of study
therapy.
* Active GI disease or other condition that will interfere significantly with
the absorption of drugs.
* Brain metastases (exceptions see protocol page 30)
* A history or evidence of cardiovascular risk (see protocol page 30 for
details).
* Pregnancy or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Overall response rate.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Progression free survival, duration of response, overall survival, safety,<br /><br>tolerability, PK.</p><br>