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NCT01970865 · OUTCOME

Percentage of Participants With Overall and Intracranial Objective Response (Phase 1)

A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations · Source last updated 2024-08-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From start of study treatment until CR or PR (maximum of 8 years approximately)

What was measured

Objective response (OR) refers to confirmed CR or PR according to RECIST version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. Results presented here were based on independent central review.

Analysis population: The ITT analysis set was used for overall response assessment and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment. Here, "Number Analyzed" signifies participants analyzed for this outcome measure.

Groups in this outcome

ALK Positive Population (Phase 1)

This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.

ROS1 Positive Population (Phase 1)

This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.

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

Analysis denominator · Participants

GroupSource count
ALK Positive Population (Phase 1)41
ROS1 Positive Population (Phase 1)12

Reported measurements

Objective response

Analysis denominator · Participants

GroupSource count
ALK Positive Population (Phase 1)41
ROS1 Positive Population (Phase 1)12
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ALK Positive Population (Phase 1)39.0Not reported24.255.5Not reported
ROS1 Positive Population (Phase 1)50.0Not reported21.178.9Not reported
Intracranial objective response

Analysis denominator · Participants

GroupSource count
ALK Positive Population (Phase 1)34
ROS1 Positive Population (Phase 1)8
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ALK Positive Population (Phase 1)41.2Not reported24.659.3Not reported
ROS1 Positive Population (Phase 1)50.0Not reported15.784.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.2
        upper Limit
        55.5
        value
        39.0
      2. group Id
        OG001
        lower Limit
        21.1
        upper Limit
        78.9
        value
        50.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        12
      units
      Participants
    title
    Objective response
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.6
        upper Limit
        59.3
        value
        41.2
      2. group Id
        OG001
        lower Limit
        15.7
        upper Limit
        84.3
        value
        50.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Intracranial objective response
denoms
  1. counts
    1. group Id
      OG000
      value
      41
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Objective response (OR) refers to confirmed CR or PR according to RECIST version 1.1. Intracranial OR refers to confirmed CR or PR considering only lesions within brain. CR was defined as the disappearance of all non-lymph node target lesions (where all target lesions are recorded with a length of 0 mm on Target Lesions eCRF). Any pathological lymph nodes (recorded as target lesion) must have reduction in short axis to \<10 mm. PR was defined as a 30 % or more decrease in SLD of target lesions, taking as reference the baseline SLD. Results presented here were based on independent central review.
dispersion Type
95% Confidence Interval
groups
  1. description
    This reporting arm includes all Phase 1 participants who had documented ALK rearrangement.
    id
    OG000
    title
    ALK Positive Population (Phase 1)
  2. description
    This reporting arm includes all Phase 1 participants who had documented ROS1 rearrangement.
    id
    OG001
    title
    ROS1 Positive Population (Phase 1)
param Type
NUMBER
population Description
The ITT analysis set was used for overall response assessment and included all enrolled participants with documented ALK or ROS1 rearrangement who received at least 1 dose of PF-06463922; participants with CNS metastases in the ITT analysis set was used for intracranial response assessment. Here, "Number Analyzed" signifies participants analyzed for this outcome measure.
reporting Status
POSTED
time Frame
From start of study treatment until CR or PR (maximum of 8 years approximately)
title
Percentage of Participants With Overall and Intracranial Objective Response (Phase 1)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice