Participant flow

Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189) · Source last updated 2024-09-20

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

groups

1. description

   Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)

   id

   FG000

   title

   Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed

2. description

   Participants received saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)

   id

   FG001

   title

   Control

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         329

      2. group Id

         FG001

         num Subjects

         181

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         64

      2. group Id

         FG001

         num Subjects

         13

      type

      Sponsor Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         9

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         410

      2. group Id

         FG001

         num Subjects

         206

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         405

      2. group Id

         FG001

         num Subjects

         202

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         84

      type

      Switched to Pembrolizumab

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         410

      2. group Id

         FG001

         num Subjects

         206

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Eighty-four participants randomized to receive Control switched over to receive pembrolizumab monotherapy. Participants receiving pembrolizumab in first course and those switching over from placebo to pembrolizumab monotherapy were eligible to receive second course of pembrolizumab monotherapy if they met certain criteria. Data from second course treatment contributed to safety data only. All primary and secondary outcome measures are based on protocol-specified cutoff (2017-11-08).

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Preserved source evidence · Not medical advice