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NCT01774721 · OUTCOME

Number of Participants With Best Overall Response (BOR) Based on IRC Review

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)

What was measured

BOR for CR/PR:\>=1 objective status (OBS) of CR/PR documented before PD; SD:\>=1 OBS of stable documented \>=8 weeks (wks) post treatment \& before PD, not qualifying as CR/PR; PD:OBS of PD within 12 wks treatment, not qualifying as CR/PR/SD; indeterminate:PD not documented within 12 wks post treatment \& no other response category applies. 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. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referring smallest sum diameters on study. 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

Complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib12Not reportedNot reportedNot reportedNot reported
Gefitinib4Not reportedNot reportedNot reportedNot reported
Partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib158Not reportedNot reportedNot reportedNot reported
Gefitinib157Not reportedNot reportedNot reportedNot reported
Stable disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib30Not reportedNot reportedNot reportedNot reported
Gefitinib27Not reportedNot reportedNot reportedNot reported
Progressive disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib12Not reportedNot reportedNot reportedNot reported
Gefitinib15Not reportedNot reportedNot reportedNot reported
Indeterminate
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dacomitinib15Not reportedNot reportedNot reportedNot reported
Gefitinib22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        4
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        158
      2. group Id
        OG001
        value
        157
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        27
    title
    Stable disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        15
    title
    Progressive disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        22
    title
    Indeterminate
denoms
  1. counts
    1. group Id
      OG000
      value
      227
    2. group Id
      OG001
      value
      225
    units
    Participants
description
BOR for CR/PR:\>=1 objective status (OBS) of CR/PR documented before PD; SD:\>=1 OBS of stable documented \>=8 weeks (wks) post treatment \& before PD, not qualifying as CR/PR; PD:OBS of PD within 12 wks treatment, not qualifying as CR/PR/SD; indeterminate:PD not documented within 12 wks post treatment \& no other response category applies. 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. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, referring smallest sum diameters on study. 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.
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
COUNT_OF_PARTICIPANTS
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
Number of Participants With Best Overall Response (BOR) Based on IRC Review
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice