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NCT01774721 · OUTCOME

Objective Response Rate (ORR) Based on Investigator Assessment

ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. · Source last updated 2023-11-14

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
Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)

What was measured

Percentage of participants with a BOR of either CR or PR based on investigator assessment recorded from the start of treatment until disease progression based on RECIST v1.1. CR: disappearance of all target lesions (TLs), non TLs; any pathological lymph nodes (LN) must reduce in short axis to \<10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (\<10 mm short axis); PR:\>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. PD:\>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions; unequivocal progression of existing non TLs.

Analysis population: ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.

Groups in this outcome

Dacomitinib

Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.

Gefitinib

Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Dacomitinib227
Gefitinib225

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dacomitinib75.3Not reported69.280.8Not reported
Gefitinib70.2Not reported63.876.1Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0924
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0924
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.2
        upper Limit
        80.8
        value
        75.3
      2. group Id
        OG001
        lower Limit
        63.8
        upper Limit
        76.1
        value
        70.2
denoms
  1. counts
    1. group Id
      OG000
      value
      227
    2. group Id
      OG001
      value
      225
    units
    Participants
description
Percentage of participants with a BOR of either CR or PR based on investigator assessment recorded from the start of treatment until disease progression based on RECIST v1.1. CR: disappearance of all target lesions (TLs), non TLs; any pathological lymph nodes (LN) must reduce in short axis to \<10 mm; normalization of tumour marker level, for non TL all LN must be non-pathological in size (\<10 mm short axis); PR:\>=30% decrease in sum of diameters of TLs, referring baseline sum diameters. PD:\>=20% increase in sum of diameters of TLs, referring smallest sum on study, sum must be an absolute increase of \>=5 mm, appearance of \>=1 new lesions; unequivocal progression of existing non TLs.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    id
    OG000
    title
    Dacomitinib
  2. description
    Participants received 250 mg of gefitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
    id
    OG001
    title
    Gefitinib
param Type
NUMBER
population Description
ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
reporting Status
POSTED
time Frame
Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)
title
Objective Response Rate (ORR) Based on Investigator Assessment
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice