Participant flow

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. · Source last updated 2022-04-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants with or without prior systemic anti-cancer therapy received Dabrafenib 150 mg BID until disease progression, death, or unacceptable adverse event(s) (AEs) or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.

   id

   FG000

   title

   Cohort A (Dabrafenib Monotherapy): Dabrafenib Monotherapy 150mg BID

2. description

   Participants who had received 1-3 prior lines of systemic anti-cancer therapies for advanced stage/metastatic disease received Dabrafenib 150 mg BID and Trametinib 2 mg once daily (OD). Treatment continued until disease progression, death, or unacceptable AEs or investigator discretion to discontinue.

   id

   FG001

   title

   Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD

3. description

   Participants who had not received any prior systemic anti-cancer for metastatic disease therapies were given Dabrafenib 150 mg BID and Trametinib 2 mg OD. Treatment continued until disease progression, death, or unacceptable AEs or at investigator discretion to discontinue.

   id

   FG002

   title

   Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         6

      type

      Study closed/terminated

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         84

      2. group Id

         FG001

         num Subjects

         57

      3. comment

         includes 34 subjects from Cohort C and 2 subjects enrolled as protocol deviations from Cohort B.

         group Id

         FG002

         num Subjects

         36

      comment

      All participants who received at least one dose of study treatment were included in the All Treated Population (ATP)

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         78

      2. group Id

         FG001

         num Subjects

         57

      3. group Id

         FG002

         num Subjects

         0

      comment

      All Treated Population who had relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease.

      type

      2nd Line Plus All Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         34

      comment

      All Treated Population who had not received any prior anti-cancer therapy for metastatic disease.

      type

      1st Line All Treated

   4. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      comment

      All Treated Population who were assigned to monotherapy cohort and elected to crossover to combination treatment following disease progression on monotherapy.

      type

      Crossover

   5. achievements

      1. group Id

         FG000

         num Subjects

         70

      2. group Id

         FG001

         num Subjects

         49

      3. group Id

         FG002

         num Subjects

         27

      comment

      Study ended when progression of disease had occurred in all patients in Cohorts B and C, a minimum of 70% of subjects had died in each cohort, or five years had passed since the last subject's first dose, whichever came first.

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         8

      3. group Id

         FG002

         num Subjects

         9

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The study was conducted in 50 sites across 11 countries: Netherlands(2), United States(15), Germany(4), Spain(7), France(8), Italy(3), Taiwan(2), South Korea(3), United Kingdom(3), Japan(2), Norway(1)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice