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

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 - BRF113928

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47910

Enrollment

Registered

2013-01-10

Start date

2013-05-16

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer

Interventions

Treatment with dabrafenib plus or minus trametinib.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Overall response rate.	—

Secondary

Measure	Time frame
Progression free survival, duration of response, overall survival, safety, tolerability, PK.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)