Participant flow

Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN) · Source last updated 2026-07-16

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

groups

1. description

   During Chemotherapy: Patients received durvalumab (D) 1500 milligrams (mg) in combination with tremelimumab (T) 75 mg intravenous (IV) infusion every 3 weeks (Q3W) for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/meters squared \[m\^2\]) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion every 4 weeks (Q4W) from Week 12 until progressive disease (PD), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.

   id

   FG000

   title

   All Patients: D + T + EP

2. description

   During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.

   id

   FG001

   title

   All Patients: D + EP

3. description

   For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.

   id

   FG002

   title

   All Patients: EP

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         15

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         270

      2. group Id

         FG001

         num Subjects

         269

      3. group Id

         FG002

         num Subjects

         296

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         329

      2. group Id

         FG001

         num Subjects

         328

      3. group Id

         FG002

         num Subjects

         330

      comment

      Randomized in overall study

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         268

      2. group Id

         FG001

         num Subjects

         268

      3. group Id

         FG002

         num Subjects

         269

      type

      Randomized and Included in Global Cohort Analysis

   3. achievements

      1. group Id

         FG000

         num Subjects

         266

      2. group Id

         FG001

         num Subjects

         265

      3. group Id

         FG002

         num Subjects

         266

      type

      Received Treatment in Global Cohort

   4. achievements

      1. group Id

         FG000

         num Subjects

         65

      2. group Id

         FG001

         num Subjects

         61

      3. group Id

         FG002

         num Subjects

         62

      type

      Randomized and Included in China Cohort Analysis

   5. achievements

      1. group Id

         FG000

         num Subjects

         65

      2. group Id

         FG001

         num Subjects

         61

      3. group Id

         FG002

         num Subjects

         62

      type

      Received Treatment in China Cohort

   6. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Included in Both Cohorts (Global + China)

   7. achievements

      1. group Id

         FG000

         num Subjects

         56

      2. group Id

         FG001

         num Subjects

         56

      3. group Id

         FG002

         num Subjects

         31

      type

      Ongoing Study at Global Cohort Final Analysis Data Cut-off (DCO)

   8. achievements

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         7

      type

      Ongoing Study at China Cohort Second (Final) Analysis DCO

   9. achievements

      1. group Id

         FG000

         num Subjects

         51

      2. group Id

         FG001

         num Subjects

         52

      3. group Id

         FG002

         num Subjects

         18

      comment

      Ongoing in overall study at long-term follow-up (LTFU) analysis DCO

      type

      COMPLETED

   10. achievements

       1. group Id

          FG000

          num Subjects

          278

       2. group Id

          FG001

          num Subjects

          276

       3. group Id

          FG002

          num Subjects

          312

       type

       NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Patients were randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab + etoposide and platinum-based chemotherapy (EP), durvalumab + EP or EP alone. 987 participants were randomized in the study overall. Patients included in both cohorts for Started, Completed and Reasons for Not Completed are not double-counted for participant flow.

recruitment Details

Study was conducted in 209 study centers across 23 countries. It included a global cohort (805 patients) and China cohort (188 patients). China cohort comprised 6 patients also in the global cohort and a further 182 patients randomized after end of global cohort recruitment. Results of the global and China cohorts were reported separately.

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

Preserved source evidence · Not medical advice