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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03164616
Recruitment Status : Active, not recruiting
First Posted : May 23, 2017
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE May 22, 2017
First Posted Date  ICMJE May 23, 2017
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2018)
  • 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 ]
  • Overall Survival (OS) [ Time Frame: Up to 4 years after first patient randomized ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2017)
  • Progression-free survival (PFS) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
  • Overall survival (OS) [ Time Frame: Up to 4 years after first patient randomized ]
  • Objective response rate (ORR) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
  • Duration of response (DoR) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
  • Time from randomization to second progression (PFS2) [ Time Frame: Up to 3 years after first patient randomized ]
  • Proportion of patients alive and progression free at 12 months from randomization (APF12) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 12 months ]
  • Best objective response (BoR) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
  • The pharmacokinetics (PK) of durvalumab and tremelimumab as determined by concentration [ Time Frame: Up to 3 years after first patient randomized ]
  • The immunogenicity of durvalumab and tremelimumab as assessed by presence of anti-drug antibodies (ADAs) [ Time Frame: Up to 3 years after first patient randomized ]
  • Health-related QoL measured by EORTC QLQ-C30 v3 [ Time Frame: Up to 3 years after first patient randomized ]
  • Disease-related symptoms measured by EORTC QLQ-LC13 [ Time Frame: Up to 3 years after first patient randomized ]
  • Changes in WHO/ECOG performance status [ Time Frame: Up to 3 years after first patient randomized ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 22, 2017)
The safety and tolerability profile of durvalumab +/- tremelimumab in combination with standard of care chemotherapy as determined by adverse events (AEs), physical examninations, laboratory data and vital signs [ Time Frame: Up to 3 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR mutations and ALK fusions, are eligible for enrollment. Patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC chemotherapy, or SoC chemotherapy alone. Tumor evaluation scans will be performed until objective disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An independent data monitoring committee (IDMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer NSCLC
Intervention  ICMJE
  • Drug: Durvalumab
    IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until disease progression or other discontinuation criteria
  • Drug: Tremelimumab
    IV infusions every 3 weeks for 12 weeks (4 cycles). An additional dose of tremelimumab will be administered in the week 16.
  • Drug: Abraxane + carboplatin
    Standard of care chemotherapy (squamous and non-squamous patients)
  • Drug: Gemcitabine + cisplatin
    Standard of care chemotherapy (squamous patients only)
  • Drug: Gemcitabine + carboplatin
    Standard of care chemotherapy (squamous patients only)
  • Drug: Pemetrexed + carboplatin
    Standard of care chemotherapy (non-squamous patients only)
  • Drug: Pemetrexed + cisplatin
    Standard of care chemotherapy (non-squamous patients only)
Study Arms  ICMJE
  • Experimental: Treatment Arm 1
    durvalumab + tremelimumab combination therapy + SoC chemotherapy
    Interventions:
    • Drug: Durvalumab
    • Drug: Tremelimumab
    • Drug: Abraxane + carboplatin
    • Drug: Gemcitabine + cisplatin
    • Drug: Gemcitabine + carboplatin
    • Drug: Pemetrexed + carboplatin
    • Drug: Pemetrexed + cisplatin
  • Experimental: Treatment Arm 2
    durvalumab monotherapy + SoC chemotherapy
    Interventions:
    • Drug: Durvalumab
    • Drug: Abraxane + carboplatin
    • Drug: Gemcitabine + cisplatin
    • Drug: Gemcitabine + carboplatin
    • Drug: Pemetrexed + carboplatin
    • Drug: Pemetrexed + cisplatin
  • Active Comparator: Treatment Arm 3
    SoC chemotherapy alone
    Interventions:
    • Drug: Abraxane + carboplatin
    • Drug: Gemcitabine + cisplatin
    • Drug: Gemcitabine + carboplatin
    • Drug: Pemetrexed + carboplatin
    • Drug: Pemetrexed + cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
1000
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2017)
801
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

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

  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil,   Bulgaria,   China,   Germany,   Hong Kong,   Hungary,   Japan,   Korea, Republic of,   Mexico,   Peru,   Poland,   Russian Federation,   South Africa,   Taiwan,   Thailand,   Ukraine,   United Kingdom,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03164616
Other Study ID Numbers  ICMJE D419MC00004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Norah Shire, M.D., Ph.D. One MedImmune Way, Gaithersburg, Maryland 20878, United States
PRS Account AstraZeneca
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP