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NCT01909453 · OUTCOME

Part (P) 2: Overall Survival (OS)

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma · Source last updated 2026-02-27

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 randomization until censoring date/death, whichever occurred 1st (up to 106.3 M of treatment exposure for P2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for P2: LGX818 300 mg; up to 111.4 M of treatment exposure for P1+P2: LGX818 300 mg)

What was measured

OS was defined as the time from the date of randomization to the date of death due to any cause. If a death was not observed by the date of analysis cutoff, OS was censored at the date of last contact.

Analysis population: FAS included all randomized participants.

Groups in this outcome

Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)

Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

Part 2: LGX818 300 mg

Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.

Part 1 + Part 2: LGX818 300 mg

Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.

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

Analysis denominator · Participants

GroupSource count
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)258
Part 2: LGX818 300 mg86
Part 1 + Part 2: LGX818 300 mg280

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)27.1Not reported21.633.3Not reported
Part 2: LGX818 300 mg19.4Not reported14.528.1Not reported
Part 1 + Part 2: LGX818 300 mg22.7Not reported19.329.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        21.6
        upper Limit
        33.3
        value
        27.1
      2. group Id
        OG001
        lower Limit
        14.5
        upper Limit
        28.1
        value
        19.4
      3. group Id
        OG002
        lower Limit
        19.3
        upper Limit
        29.3
        value
        22.7
denoms
  1. counts
    1. group Id
      OG000
      value
      258
    2. group Id
      OG001
      value
      86
    3. group Id
      OG002
      value
      280
    units
    Participants
description
OS was defined as the time from the date of randomization to the date of death due to any cause. If a death was not observed by the date of analysis cutoff, OS was censored at the date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    OG000
    title
    Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
  2. description
    Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
    id
    OG001
    title
    Part 2: LGX818 300 mg
  3. description
    Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.
    id
    OG002
    title
    Part 1 + Part 2: LGX818 300 mg
param Type
MEDIAN
population Description
FAS included all randomized participants.
reporting Status
POSTED
time Frame
From randomization until censoring date/death, whichever occurred 1st (up to 106.3 M of treatment exposure for P2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for P2: LGX818 300 mg; up to 111.4 M of treatment exposure for P1+P2: LGX818 300 mg)
title
Part (P) 2: Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice