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NCT01283516 · OUTCOME

Duration of Response (DOR) Based on Investigator Assessment

A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase · Source last updated 2019-03-15

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
275 weeks

What was measured

Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.

Analysis population: Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and had a confirmed overall complete response or partial response after initiation of LDK378.

Groups in this outcome

NSCLC With Prior ALKi (Arms 1A + 1B)

Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.

NSCLC ALKi Naive (Arm 2)

Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.

All NSCLC

all NSCLC patients.

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

Analysis denominator · Participants

GroupSource count
NSCLC With Prior ALKi (Arms 1A + 1B)92
NSCLC ALKi Naive (Arm 2)61
All NSCLC153

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
NSCLC With Prior ALKi (Arms 1A + 1B)8.25Not reported6.809.69Not reported
NSCLC ALKi Naive (Arm 2)14.19Not reported11.2722.11Not reported
All NSCLC10.12Not reported8.3111.63Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.80
        upper Limit
        9.69
        value
        8.25
      2. group Id
        OG001
        lower Limit
        11.27
        upper Limit
        22.11
        value
        14.19
      3. group Id
        OG002
        lower Limit
        8.31
        upper Limit
        11.63
        value
        10.12
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      61
    3. group Id
      OG002
      value
      153
    units
    Participants
description
Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.0.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
    id
    OG000
    title
    NSCLC With Prior ALKi (Arms 1A + 1B)
  2. description
    Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.
    id
    OG001
    title
    NSCLC ALKi Naive (Arm 2)
  3. description
    all NSCLC patients.
    id
    OG002
    title
    All NSCLC
param Type
MEDIAN
population Description
Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group and had a confirmed overall complete response or partial response after initiation of LDK378.
reporting Status
POSTED
time Frame
275 weeks
title
Duration of Response (DOR) Based on Investigator Assessment
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice