Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.

Conditions

• Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dabrafenib — DRUG
  Dabrafenib study treatment was provided as 50 mg and 75 mg hydroxypropyl methylcellulose (HPMC) capsules. Each capsule contains 50 mg or 75 mg of free base (present as the mesylate salt)
• Trametinib — DRUG
  Trametinib study treatment was provided as 0.5 mg and 2 mg tablets. Each tablet contained 0.5 mg or 2 mg of trametinib parent (present as the dimethyl sulfoxide solvate)

Study Details

This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Central confirmation testing for the BRAF V600E mutation was performed and a sufficient number of subjects were enrolled with the intent of having at least 125 centrally confirmed subjects among the three cohorts.

Key Dates

Start date

Aug 5, 2011

Status verified

Mar 2022

Primary completion

Oct 1, 2015

Completion

Jan 7, 2021

Study Design

Enrollment

177 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Cohort A (Dabrafenib Monotherapy)
  Participants received Dabrafenib 150mg BID and continued treatment until disease progression, death, or unacceptable adverse event. Participants receiving and adequately tolerating dabrafenib as a single agent and who continue to meet the inclusion and exclusion criteria had the option to switch to Dabrafenib (150 mg BID) and Trametinib (2 mg once daily) combination treatment within 4 weeks of radiologic disease progression with prior approval from a medical monitor.
• Experimental: Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E
  Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.
• Experimental: Cohort C - Double Combination (Dabrafenib+Trametinib) naive mBRAF V600E
  Participants received Dabrafenib 150 mg BID in combination with Trametinib 2 mg once daily and continued treatment until disease progression, death, or unacceptable adverse event.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: From study treatment start date until first documented complete response or partial response, assessed up to approximately 50 months ]

Locations (15)

Find similar trials in Los Angeles, CA

Related Studies

• Evaluation of Late Effects and Natural History of Disease in Patients Treated With Radiotherapy
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Collection of Blood and Urine From Patients Undergoing Radiation Therapy
  Enrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland
• Evaluation of Non-Invasive Assays for the Detection of Urothelial Cancer
  Recruiting · Lahey Clinic · Burlington, Massachusetts
• Data Collection, Clinical Care and Interventions in CCR, NCI
  Enrolling By Invitation · National Cancer Institute (NCI) · Bethesda, Maryland