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Clinical Trials List

Protocol NumberD419MC00004
NCT Number(ClinicalTrials.gov Identfier)NCT03164616
Active

2017-05-01 - 2020-07-31

Phase III

Recruiting2

Terminated8

ICD-10C34

Malignant neoplasm of bronchus and lung

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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) (POSEIDON)

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

    QPS-QUALITIX CLINICAL RESEARCH CO., LTD.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/11

Investigators and Locations

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 Recruiting

Audit

CRO

Principal Investigator 魏裕峰 無
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator 李建德 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

15 Terminated

Audit

CRO

Principal Investigator Cheng-Ta Yang
Linkou Chang Gung Medical Foundation

Taiwan National PI

楊政達

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

12 Terminated

Audit

None

Condition/Disease

Non Small Cell Lung Cancer NSCLC

Objectives

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Test Drug

Durvalumab / Tremelimumab

Active Ingredient

Durvalumab: Humanized anti-PD-L1 mAb
Tremelimumab: Humanized anti-CTLA-4 mAb

Dosage Form

Injection

Dosage

50 mg/mL
20 mg/mL

Endpoints

Progression-Free Survival (PFS); D + SoC Compared With SoC Alone 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 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).

Inclution Criteria

For inclusion in the study, patients should fulfill the following criteria:

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

Exclusion Criteria

Patients should not enter the study if any of the following exclusion criteria are fulfilled:

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

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    1000 participants

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