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Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

NCT03164616 · POSEIDON Phase 3Active, not recruiting

Lead sponsor
AstraZeneca (Industry)
Enrollment
1,186 (actual)
Start date
1 Jun 2017
Primary completion
12 Mar 2021 (actual)
Study completion
15 Nov 2027
Last update posted
13 Mar 2026

Design

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

Interventions

  • Durvalumab Drug
  • Tremelimumab Drug
  • Abraxane + carboplatin Drug
  • Gemcitabine + cisplatin Drug
  • Gemcitabine + carboplatin Drug
  • Pemetrexed + carboplatin Drug
  • Pemetrexed + cisplatin Drug

Conditions and primary outcome

  • Non Small Cell Lung Cancer NSCLC

Primary outcome

Progression-Free Survival (PFS); D + SoC Compared With SoC Alone (Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).); Overall Survival (OS); D + SoC Compared With SoC Alone (From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT03164616 (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. Progression-Free Survival (PFS); D + SoC Compared With SoC Alone

    Time frame
    Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).
    Measure
    Median
    Unit
    months

    • D + SoC vs SoC AloneSuperiority

      D + SoC vs SoC alone. A hazard ratio (HR) \<1 favors D + SoC to be associated with a longer PFS than SoC alone.

      Estimate
      0.74Hazard Ratio (HR)
      95% CI, two-sided
      0.620 to 0.885
      p-value
      0.00093
      Method
      Log Rank

  2. Overall Survival (OS); D + SoC Compared With SoC Alone

    Time frame
    From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).
    Measure
    Median
    Unit
    months

    • D + SoC vs SoC AloneSuperiority

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

      Estimate
      0.86Hazard Ratio (HR)
      95% CI, two-sided
      0.724 to 1.016
      p-value
      0.07581
      Method
      Log Rank

Serious adverse events

Time frame: Adverse events: from first dose of study treatment until the earlier of 90 days after last dose or the date of first subsequent anticancer therapy. All-cause mortality (death due to any cause): from randomization up to global cohort final analysis DCO (12 March 2021). Maximum timeframe of approximately 45 months.

Participants with serious adverse events per group for POSEIDON, as posted
GroupAffectedAt risk
T + D + SoC146330
D + SoC134334
SoC Alone117333

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

3 on PubMed

  1. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy in First-Line Metastatic NSCLC: Five-Year Overall Survival Outcomes From the Phase 3 POSEIDON Trial.

    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2025 Jan

    PubMed 39243945 (opens in a new tab)DOI 10.1016/j.jtho.2024.09.1381 (opens in a new tab)

  2. Population Pharmacokinetics and Exposure-Response Analysis for the CTLA-4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study.

    Clinical pharmacology and therapeutics · 2023 Dec

    PubMed 37777827 (opens in a new tab)DOI 10.1002/cpt.3063 (opens in a new tab)

  3. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study.

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023 Feb 20

    PubMed 36327426 (opens in a new tab)DOI 10.1200/JCO.22.00975 (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.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

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.