NCT01336634 · OUTCOME

All Collected Deaths

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.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: up to 81 months (study treatment with dabrafenib and trametinib), up to approximately 9 years (study duration)

What was measured

On treatment deaths were collected from FPFT up to 30 days after study drug discontinuation, for a maximum duration with dabrafenib and trametinib of 81 months (study treatment with dabrafenib and trametinib ranged from 0.3 to 80.0 months). Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 9 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.

Analysis population: Clinical database population; all treated patients.

Groups in this outcome

Cohort A (Dabrafenib Monotherapy)

Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.

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

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.

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

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.

Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD

Crossover - Double Combination (Dabrafenib+Trametinib): 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Cohort A (Dabrafenib Monotherapy)	84
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD	57
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD	36
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD	20

Reported measurements

On-treatment deaths

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A (Dabrafenib Monotherapy)	15	Not reported	Not reported	Not reported	Not reported
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD	12	Not reported	Not reported	Not reported	Not reported
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD	5	Not reported	Not reported	Not reported	Not reported
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD	4	Not reported	Not reported	Not reported	Not reported

Post-treatment deaths

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A (Dabrafenib Monotherapy)	38	Not reported	Not reported	Not reported	Not reported
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD	38	Not reported	Not reported	Not reported	Not reported
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD	21	Not reported	Not reported	Not reported	Not reported
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD	13	Not reported	Not reported	Not reported	Not reported

All deaths

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A (Dabrafenib Monotherapy)	53	Not reported	Not reported	Not reported	Not reported
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD	50	Not reported	Not reported	Not reported	Not reported
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD	26	Not reported	Not reported	Not reported	Not reported
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD	17	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
15
group Id
OG001
value
12
group Id
OG002
value
5
group Id
OG003
value
4
title
On-treatment deaths
categories
measurements
group Id
OG000
value
38
group Id
OG001
value
38
group Id
OG002
value
21
group Id
OG003
value
13
title
Post-treatment deaths
categories
measurements
group Id
OG000
value
53
group Id
OG001
value
50
group Id
OG002
value
26
group Id
OG003
value
17
title
All deaths

denoms

counts
group Id
OG000
value
84
group Id
OG001
value
57
group Id
OG002
value
36
group Id
OG003
value
20
units
Participants

description

groups

description
Participants who have relapsed or progressed after receiving at least one line of prior anti-cancer therapy for metastatic disease received dabrafenib 150 mg BID. It was continued until disease progression or death or unacceptable AEs or investigator discretion to discontinue or decision to crossover from monotherapy to combination therapy.
id
OG000
title
Cohort A (Dabrafenib Monotherapy)
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
OG001
title
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD
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
OG002
title
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD
description
Crossover - Double Combination (Dabrafenib+Trametinib): 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.
id
OG003
title
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD

param Type

COUNT_OF_PARTICIPANTS

population Description

Clinical database population; all treated patients.

reporting Status

POSTED

time Frame

up to 81 months (study treatment with dabrafenib and trametinib), up to approximately 9 years (study duration)

title

All Collected Deaths

type

POST_HOC

unit Of Measure

Participants

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

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