Participant flow

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.

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

   FG000

   title

   Dacomitinib

2. description

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

   id

   FG001

   title

   Gefitinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         133

      2. group Id

         FG001

         num Subjects

         152

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         7

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Did not meet eligibility criteria

   5. reasons

      1. group Id

         FG000

         num Subjects

         58

      2. group Id

         FG001

         num Subjects

         49

      type

      Other reasons and patients who completed the 48-month follow-up period

   6. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      type

      Study terminated by sponsor

   7. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      type

      Disease progression

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         227

      2. group Id

         FG001

         num Subjects

         225

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         227

      2. group Id

         FG001

         num Subjects

         224

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         227

      2. group Id

         FG001

         num Subjects

         225

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The study completed enrollment on 25 Mar 2015 with 452 participants randomized, 227 participants to the dacomitinib arm and 225 participants to the gefitinib arm. After the last data cutoff (DCO) date of 13 May 2019, 11 participants remained in the study to continue dacomitinib treatment. All 11 participants were discontinued from the study by last participant last visit (LPLV) on 27 Jan 2022.

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

Preserved source evidence · Not medical advice