Participant flow

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer · Source last updated 2026-01-05

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

groups

1. description

   Participants were randomized to receive treatment according to the local SOC chemotherapy (lurbinectedin, topotecan, or amrubicin \[Japan only\]) in 21-day cycles.

   id

   FG000

   title

   Standard of Care (SOC)

2. description

   Participants were randomized to receive tarlatamab as an intravenous (IV) infusion: A step dose of 1 mg on Cycle 1 Day 1 followed by the target dose 10 mg on Cycle 1 Day 8, Cycle 1 Day 15, and every 2 weeks (Q2W) thereafter.

   id

   FG001

   title

   Tarlatamab 1 mg to 10 mg Q2W

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         151

      2. group Id

         FG001

         num Subjects

         111

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         102

      2. group Id

         FG001

         num Subjects

         143

      type

      Ongoing in study

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         255

      2. group Id

         FG001

         num Subjects

         254

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         255

      2. group Id

         FG001

         num Subjects

         254

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomized 1:1 to receive tarlatamab or standard of care (SOC) chemotherapy (lurbinectedin, topotecan , or amrubicin \[Japan only\]). Randomization was stratified by prior anti-programmed cell death 1 (PD-1) or prior anti-PD-Ligand (L)1 (yes/no), chemotherapy-free interval (≥180 days; \<180 to ≥90 days; \<90 days), presence of brain metastases (yes/no), and SOC (topotecan/amrubicin versus lurbinectedin).

recruitment Details

Participants were enrolled at 166 centers in 30 countries worldwide starting from 31 May 2023. The primary analysis data is presented from the date of randomization up to the data cutoff date (DCO), 29 January 2025. The study is still ongoing.

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Preserved source evidence · Not medical advice