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

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ClinicalTrials.gov Identifier: NCT03164616
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer NSCLC Drug: Durvalumab Drug: Tremelimumab Drug: Abraxane + carboplatin Drug: Gemcitabine + cisplatin Drug: Gemcitabine + carboplatin Drug: Pemetrexed + carboplatin Drug: Pemetrexed + cisplatin Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm 1
durvalumab + tremelimumab combination therapy + SoC chemotherapy
 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)
Experimental: Treatment Arm 2
durvalumab monotherapy + SoC chemotherapy
 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: 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)
Active Comparator: Treatment Arm 3
SoC chemotherapy alone
 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Overall Survival (OS) [ Time Frame: Up to 4 years after first patient randomized ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
  2. Overall survival (OS) [ Time Frame: Up to 4 years after first patient randomized ]
  3. Objective response rate (ORR) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
  4. Duration of response (DoR) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
  5. Time from randomization to second progression (PFS2) [ Time Frame: Up to 3 years after first patient randomized ]
  6. 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 ]
  7. Best objective response (BoR) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
  8. The pharmacokinetics (PK) of durvalumab and tremelimumab as determined by concentration [ Time Frame: Up to 3 years after first patient randomized ]
  9. 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 ]
  10. Health-related QoL measured by EORTC QLQ-C30 v3 [ Time Frame: Up to 3 years after first patient randomized ]
  11. Disease-related symptoms measured by EORTC QLQ-LC13 [ Time Frame: Up to 3 years after first patient randomized ]
  12. Changes in WHO/ECOG performance status [ Time Frame: Up to 3 years after first patient randomized ]

Other Outcome Measures:
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164616


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locator Service 1-877-400-4656 AstraZeneca@emergingmed.com

Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Norah Shire, M.D., Ph.D. One MedImmune Way, Gaithersburg, Maryland 20878, United States
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03164616    
Other Study ID Numbers: D419MC00004
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting Materials: Study Protocol
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
NSCLC
PD-L1
Durvalumab
Tremelimumab
 PFS
Overall survival (OS)
Tumor Mutational Burden (TMB)
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Carboplatin
Pemetrexed
Durvalumab
 Albumin-Bound Paclitaxel
Tremelimumab
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Antineoplastic Agents, Immunological