Participant flow

A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604) · Source last updated 2022-10-03

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

groups

1. description

   During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.

   id

   FG000

   title

   Pembrolizumab+EP

2. description

   During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).

   id

   FG001

   title

   Placebo+EP

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         195

      2. group Id

         FG001

         num Subjects

         205

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         7

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         228

      2. group Id

         FG001

         num Subjects

         225

      type

      STARTED

   2. achievements

      1. comment

         1 participant randomized to the pembrolizumab+EP arm was treated with placebo+EP.

         group Id

         FG000

         num Subjects

         223

      2. group Id

         FG001

         num Subjects

         223

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Received Second Course of Pembrolizumab

   4. achievements

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         13

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         200

      2. group Id

         FG001

         num Subjects

         212

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

One participant who was randomized to the pembrolizumab+EP arm was inadvertently treated with placebo+EP. For efficacy analyses this participant will be included in the arm they were initially randomized into and for safety analyses the participant will be included by treatment received.

recruitment Details

Participants in the pembrolizumab+ chemotherapy (etoposide/platinum \[EP\]) arm were eligible to receive second course treatment with pembrolizumab if they met criteria for re-treatment. Per protocol, response, progression, or patient reported outcomes during the second course were not counted towards efficacy outcome measures and adverse events during the second course were not counted towards safety outcome measures.

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Preserved source evidence · Not medical advice