NCT01336634 · OUTCOME

Duration of Response (DoR) Based on Local Investigator Assessment

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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to approximately 113 months

What was measured

Duration of Response (DoR) was defined as the time from the first documented occurrence of response (PR or CR) until the date of the first documented progression based on RECIST v1.1 or death.

Analysis population: All Treated Population (ATP). Only responders (PR or CR) were included in the analysis.

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)	27
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD	39
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD	23
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD	4

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Cohort A (Dabrafenib Monotherapy)	11.8	Not reported	5.4	23.5	Not reported
Cohort B - Double Combination (Dabrafenib+Trametinib) mBRAF V600E: DAB 150MG BID, TRA 2mG QD	9.8	Not reported	6.9	18.3	Not reported
Cohort C - Double Combination (Dabrafenib+Trametinib) Naive mBRAF V600E: DAB 150MG BID, TRA 2mG QD	10.2	Not reported	8.3	15.2	Not reported
Crossover - Double Combination (Dabrafenib+Trametinib): DAB 150MG BID, TRA 2mG QD	13.4	Not reported	7.6	19.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
5.4
upper Limit
23.5
value
11.8
group Id
OG001
lower Limit
6.9
upper Limit
18.3
value
9.8
group Id
OG002
lower Limit
8.3
upper Limit
15.2
value
10.2
group Id
OG003
lower Limit
7.6
upper Limit
19.3
value
13.4

denoms

counts
group Id
OG000
value
27
group Id
OG001
value
39
group Id
OG002
value
23
group Id
OG003
value
4
units
Participants

description

Duration of Response (DoR) was defined as the time from the first documented occurrence of response (PR or CR) until the date of the first documented progression based on RECIST v1.1 or death.

dispersion Type

95% Confidence Interval

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

MEDIAN

population Description

All Treated Population (ATP). Only responders (PR or CR) were included in the analysis.

reporting Status

POSTED

time Frame

From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to approximately 113 months

title

Duration of Response (DoR) Based on Local Investigator Assessment

type

SECONDARY

unit Of Measure

Months

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