Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00932893 · OUTCOME

Overall Survival (OS)

An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene · Source last updated 2017-01-02

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
Randomization until death (up to 4.5 years)

What was measured

OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.

Analysis population: FAS included all participants who were randomized to study treatment.

Groups in this outcome

Crizotinib

Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

Chemotherapy

Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.

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

Analysis denominator · Participants

GroupSource count
Crizotinib173
Chemotherapy174

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Crizotinib21.7Not reported18.930.5Not reported
Chemotherapy21.9Not reported16.826.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.661
    ci Pct Value
    95
    ci Upper Limit
    1.104
    group Description
    P-value was obtained from 1-sided log-rank test stratified by ECOG PS score, brain metastases, and prior EGFR TKI treatment. The hazard ratio and corresponding 95% CI from the stratified Cox proportional hazards model were also presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1145
    p Value Comment
    Statistical significance: 1-sided at alpha=0.025
    param Type
    Hazard Ratio (HR)
    param Value
    0.854
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.661
    ci Pct Value
    95
    ci Upper Limit
    1.104
    group Description
    P-value was obtained from 1-sided log-rank test stratified by ECOG PS score, brain metastases, and prior EGFR TKI treatment. The hazard ratio and corresponding 95% CI from the stratified Cox proportional hazards model were also presented.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1145
    p Value Comment
    Statistical significance: 1-sided at alpha=0.025
    param Type
    Hazard Ratio (HR)
    param Value
    0.854
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.9
        upper Limit
        30.5
        value
        21.7
      2. group Id
        OG001
        lower Limit
        16.8
        upper Limit
        26.0
        value
        21.9
denoms
  1. counts
    1. group Id
      OG000
      value
      173
    2. group Id
      OG001
      value
      174
    units
    Participants
description
OS: Time in months from randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4.
dispersion Type
95% Confidence Interval
groups
  1. description
    Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
    id
    OG000
    title
    Crizotinib
  2. description
    Pemetrexed 500 mg/m\^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m\^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
FAS included all participants who were randomized to study treatment.
reporting Status
POSTED
time Frame
Randomization until death (up to 4.5 years)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice