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
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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 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment Arm 1
durvalumab + tremelimumab combination therapy + SoC chemotherapy
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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) |
- 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 ]
- 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 ]
- 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 ]

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

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
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 |

Study Director: | Norah Shire, M.D., Ph.D. | One MedImmune Way, Gaithersburg, Maryland 20878, United States |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
NSCLC PD-L1 Durvalumab Tremelimumab |
PFS Overall survival (OS) Tumor Mutational Burden (TMB) |
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 |