Participant flow

Study of Pembrolizumab (MK-3475) Versus Platinum-Based Chemotherapy for Participants With Programmed Cell Death-Ligand 1 (PD-L1)-Positive Advanced or Metastatic Non-Small Cell Lung Cancer (MK-3475-042/KEYNOTE-042) · Source last updated 2026-06-25

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 by intravenous (IV) infusion on Day 1 every 3 weeks (Q3W) for a maximum of 35 cycles (21-day cycles). Some participants may have been eligible for re-treatment with pembrolizumab monotherapy after they had experienced radiographic disease as per protocol-defined criteria.

   id

   FG000

   title

   Pembrolizumab

2. description

   Participants received carboplatin at target dose Area Under Curve (AUC) 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + paclitaxel 200 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles) OR carboplatin target dose AUC 5 (maximum dose 750 mg) or AUC 6 (maximum dose 900 mg) + pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W for a maximum of 6 cycles (21-day cycles). Participants with non-squamous histologies received optional additional maintenance treatment with pemetrexed 500 mg/m\^2 by IV infusion on Day 1 Q3W

   id

   FG001

   title

   Chemotherapy (Standard of Care [SOC] Treatment)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         127

      2. group Id

         FG001

         num Subjects

         74

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         418

      2. group Id

         FG001

         num Subjects

         508

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Site Terminated by Sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         80

      2. group Id

         FG001

         num Subjects

         41

      type

      Participation in Study Terminated by Sponsor

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Parent/Guardian

   7. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         9

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. comment

         1 additional participant was randomized in error

         group Id

         FG000

         num Subjects

         637

      2. group Id

         FG001

         num Subjects

         637

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         636

      2. group Id

         FG001

         num Subjects

         615

      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

         637

      2. group Id

         FG001

         num Subjects

         637

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Pembrolizumab-treated participants, who attained a confirmed complete response (CR) or who stopped trial treatment after 35 administrations of study medication for reasons other than disease progression or intolerability, could consider stopping trial treatment. These participants may have been eligible for re-treatment with pembrolizumab monotherapy after they had experienced radiographic disease as per protocol-defined criteria.

recruitment Details

Of the 1275 participants randomized (pembrolizumab=638, chemotherapy=637), 1 participant assigned to receive pembrolizumab died prior to randomization and was randomized in error. The intent to treat population was defined as participants alive at the time of randomization, so the actual randomized population included 637 participants in each arm.

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

Preserved source evidence · Not medical advice