POSEIDON

A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223617

Enrollment

Registered

2017-08-17

Start date

2017-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer NSCLC

Interventions

investigational material(s) Generic name etc : Durvalumab, Tremelimumab, Abraxane + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + carboplatin, Pemetrexed + cisplatin IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged at least 18 years. 2. Histologically or cytologically documented Stage IV NSCLC. 3. Confirmed tumor PD-L1 status prior to randomization. 4. Patients must have tumors that lack activating EGFR mutations and ALK fusions. 5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC. 6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines.

Exclusion criteria

Exclusion criteria: 1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant. 2. Active or prior documented autoimmune or inflammatory disorders. 3. Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids. 4. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.

Design outcomes

Primary

Measure	Time frame
[Current] - 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).] - PFS (per RECIST version 1.1 [RECIST 1.1] using Blinded Independent Central Review [BICR] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-specified after approximately 497 BICR PFS events occurred across the D + SoC and SoC alone treatment arms (75% maturity). - 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).] - OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The final analysis of OS in the global cohort was pre-specified after approximately 532 OS events occurred across the D + SoC and SoC alone treatment arms (80% maturity). [Original] Progression-free survival (PFS) using Blinded Independent Central Review (BICR) assessments according to RECIST 1.1 [Time Frame: Up to 3 years after first patient randomized]	—

Measure

Time frame

[Current] - 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).] - PFS (per RECIST version 1.1 [RECIST 1.1] using Blinded Independent Central Review [BICR] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-specified after approximately 497 BICR PFS events occurred across the D + SoC and SoC alone treatment arms (75% maturity). - 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).] - OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The final analysis of OS in the global cohort was pre-specified after approximately 532 OS events occurred across the D + SoC and SoC alone treatment arms (80% maturity). [Original] Progression-free survival (PFS) using Blinded Independent Central Review (BICR) assessments according to RECIST 1.1 [Time Frame: Up to 3 years after first patient randomized]

—

Countries

Brazil, Bulgaria, China, Germany, Hong Kong, Hungary, Mexico, Peru, Poland, Russian Federation, South Africa, South Korea, Taiwan, Thailand, Ukraine, United Kingdom, United States of America, Vietnam

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026