Participant flow

Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy · Source last updated 2025-11-21

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

groups

1. description

   Participants received durvalumab monotherapy (1500 milligram \[mg\] for participants \>30 kilogram \[kg\] in weight and a weight-based dosing equivalent to 20 mg/kg for participants \<=30 kg in weight) via intravenous (IV) infusion once every 4 weeks (q4w), until clinical/Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.

   id

   FG000

   title

   Durvalumab

2. description

   Participants received durvalumab in combination with tremelimumab (1500 mg durvalumab in combination with 75 mg tremelimumab for participants \>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg durvalumab in combination with 1 mg/kg tremelimumab for participants \<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.

   id

   FG001

   title

   Durvalumab Plus Tremelimumab

3. description

   Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.

   id

   FG002

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         115

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         144

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         11

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         140

      2. group Id

         FG001

         num Subjects

         200

      3. group Id

         FG002

         num Subjects

         111

      type

      Ongoing at the time of DCO

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         264

      2. group Id

         FG001

         num Subjects

         200

      3. group Id

         FG002

         num Subjects

         266

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         262

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         265

      type

      Safety Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         264

      2. group Id

         FG001

         num Subjects

         200

      3. group Id

         FG002

         num Subjects

         266

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Based on the results of the secondary objectives at the interim analysis (reviewed by an unblinded independent data monitoring committee \[IDMC\]), data for the D+T arm were to remain blinded to the Sponsor as pre-specified in the study's unblinding plan. Since the D+T arm was blinded at the time of posting the results from this interim analysis, results for that arm will be posted at the time of final analysis.

recruitment Details

This Phase III, double-blind, placebo-controlled trial studied participants with limited stage small-cell lung cancer who had not progressed after concurrent chemoradiation therapy at 164 sites in 19 countries. Interim results are based on data cut-off (DCO) date of 15 January 2024. 730 participants were randomized; the first 600 in a 1:1:1 ratio to durvalumab monotherapy (D), durvalumab plus tremelimumab combination therapy (D+T) or placebo (P), the remaining in a 1:1 ratio to D or P.

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

Preserved source evidence · Not medical advice