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Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)

NCT03043872 · CASPIAN Phase 3Active, not recruiting

Lead sponsor
AstraZeneca (Industry)
Enrollment
987 (actual)
Start date
27 Mar 2017
Primary completion
27 Jan 2020 (actual)
Study completion
31 Dec 2026
Last update posted
16 Jul 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
3

Interventions

  • Durvalumab Drug
  • Tremelimumab Drug
  • Carboplatin Drug
  • Cisplatin Drug
  • Etoposide Drug

Conditions and primary outcome

  • Small Cell Lung Carcinoma Extensive Disease

Primary outcome

Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP (From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months).); OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP (From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).); OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP (From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months).); OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP (From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03043872 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP

    Time frame
    From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months).
    Measure
    Median
    Unit
    months

    • Global Cohort: D + EP vs Global Cohort: EPSuperiority

      D + EP vs EP. The global cohort interim analysis of OS was based on a Lan-DeMets alpha spending function with O'Brien Fleming type boundary, using the actual number of events observed as a proportion of the planned total. Boundary for declaring statistical significance was 0.0178 for a 4% overall alpha. Hazard Ratio (HR) \<1 favors D + EP to be associated with a longer OS than EP.

      Estimate
      0.73Hazard Ratio (HR)
      95% CI, two-sided
      0.591 to 0.909
      p-value
      0.0047
      Method
      Log Rank

  2. OS in the Global Cohort; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP

    Time frame
    From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).
    Measure
    Median
    Unit
    months

    • Global Cohort: D + EP vs Global Cohort: EPSuperiority

      D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP.

      Estimate
      0.75Hazard Ratio (HR)
      95% CI, two-sided
      0.625 to 0.910
      p-value
      0.0032
      Method
      Log Rank

    • Global Cohort: D + T + EP vs Global Cohort: EPSuperiority

      D + T + EP vs EP. The alpha level applied at the global cohort final analysis was adjusted (using a generalized Haybittle-Peto method) to account for actual alpha spent at the interim analysis based on the actual final total number of events, and thus maintain control of overall Type I error. Boundary for declaring statistical significance was 0.0418 for a 5% overall alpha. HR \<1 favors D + T + EP to be associated with a longer OS than EP.

      Estimate
      0.82Hazard Ratio (HR)
      95% CI, two-sided
      0.682 to 0.995
      p-value
      0.0451
      Method
      Log Rank

  3. OS in the China Cohort; Assessed at China Cohort First Analysis; D + EP Compared With EP

    Time frame
    From baseline until death due to any cause. Assessed until China cohort first analysis DCO (maximum of approximately 19 months).
    Measure
    Median
    Unit
    months

    • China Cohort: D + EP vs China Cohort: EPOther

      D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.

      Estimate
      0.65Hazard Ratio (HR)
      95% CI, two-sided
      0.414 to 1.029
      p-value
      0.0664
      Method
      Log Rank

  4. OS in the China Cohort; Assessed at China Cohort Second Analysis; D + EP Compared With EP and D + T + EP Compared With EP

    Time frame
    From baseline until death due to any cause. Assessed until China cohort second analysis DCO (maximum of approximately 29 months).
    Measure
    Median
    Unit
    months

    • China Cohort: D + EP vs China Cohort: EPOther

      D + EP vs EP. HR \<1 favors D + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.

      Estimate
      0.75Hazard Ratio (HR)
      95% CI, two-sided
      0.504 to 1.106
      p-value
      0.1455
      Method
      Log Rank

    • China Cohort: D + T + EP vs China Cohort: EPOther

      D + T + EP vs EP. HR \<1 favors D + T + EP to be associated with a longer OS than EP. The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.

      Estimate
      0.65Hazard Ratio (HR)
      95% CI, two-sided
      0.439 to 0.964
      p-value
      0.0314
      Method
      Log Rank

Serious adverse events

Time frame: All treatment-emergent adverse events (TEAEs) were collected up to the final analysis DCO for each cohort; maximum of approximately 33 months for the Global cohort and maximum of approximately 29 months for the China cohort. Serious AEs and Deaths were collected through LTFU analysis in patients still receiving durvalumab (or within 90 days of discontinuing treatment); up to approximately 4 years.

Participants with serious adverse events per group for CASPIAN, as posted
GroupAffectedAt risk
Global Cohort: D + T + EP126266
Global Cohort: D + EP86265
Global Cohort: EP97266
China Cohort: D + T + EP3165
China Cohort: D + EP2661
China Cohort: EP2262

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

4 on PubMed

  1. Adverse events self-reported by patients with extensive-stage small-cell lung cancer in the phase III CASPIAN study.

    Future oncology (London, England) · 2025 May

    PubMed 40331625 (opens in a new tab)DOI 10.1080/14796694.2025.2491297 (opens in a new tab)

  2. Molecular classification and biomarkers of outcome with immunotherapy in extensive-stage small-cell lung cancer: analyses of the CASPIAN phase 3 study.

    Molecular cancer · 2024 May 30

    PubMed 38811992 (opens in a new tab)DOI 10.1186/s12943-024-02014-x (opens in a new tab)

  3. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial.

    The Lancet. Oncology · 2021 Jan

    PubMed 33285097 (opens in a new tab)DOI 10.1016/S1470-2045(20)30539-8 (opens in a new tab)

  4. Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial.

    Lancet (London, England) · 2019 Nov 23

    PubMed 31590988 (opens in a new tab)DOI 10.1016/S0140-6736(19)32222-6 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

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Data integrity

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Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.