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Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE). (NEPTUNE)

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ClinicalTrials.gov Identifier: NCT02542293
Recruitment Status : Active, not recruiting
First Posted : September 7, 2015
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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 versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

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

Detailed Description:
Patients will be randomized in a 1:1 to receive treatment with durvalumab + tremelimumab combination therapy or SoC therapy. The primary objective of this study is to assess the efficacy of combination treatment compared with SoC in terms of Overall Survival (OS) in patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 955 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)
Actual Study Start Date : November 3, 2015
Estimated Primary Completion Date : August 22, 2019
Estimated Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: Combination Therapy
Durvalumab (PD-L1 monoclonal antibody) + Tremelimumab (monoclonal antibody directed against CTLA-4)
Biological: Durvalumab +Tremelimumab
Active Comparator: Standard of Care
Standard of Care chemotherapy treatment
Drug: Paclitaxel + carboplatin
Chemotherapy Agents
Other Name: Platinum based Standard of Care Chemotherapy

Drug: Gemcitabine + cisplatin
Chemotherapy Agents
Other Name: Platinum based Standard of Care Chemotherapy

Drug: Gemcitabine + carboplatin
Chemotherapy Agents
Other Name: Platinum based Standard of Care Chemotherapy

Drug: Pemetrexed + cisplatin
Chemotherapy Agent
Other Name: Platinum based Standard of Care Chemotherapy

Drug: Pemetrexed + carboplatin
Chemotherapy Agent
Other Name: Platinum based Standard of Care Chemotherapy




Primary Outcome Measures :
  1. To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to Standard of Care (SoC) in terms of Overall Survival (OS) in patients with bTMB ≥ 20mut/Mb [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    Assess the Overall Survival


Secondary Outcome Measures :
  1. To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of OS [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    Additional bTMB defined populations, PD-L1 negative NSCLC, all patients with NSCLC

  2. To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Progression-free survival (PFS) [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    bTMB defined populations, PD-L1 negative NSCLC, all patients with NSCLC

  3. To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Objective response rate (ORR) [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    bTMB defined populations, PD-L1 negative NSCLC, all patients with NSCLC

  4. To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Duration of response (DoR) [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    bTMB defined populations, PD-L1 negative NSCLC, all patients with NSCLC

  5. To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Proportion of patients alive at 12 months (OS12) [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    bTMB defined populations, PD-L1 negative NSCLC, all patients with NSCLC

  6. To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of OS18 [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    bTMB defined populations, PD-L1 negative NSCLC, all patients with NSCLC

  7. To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of OS24 [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    bTMB defined populations, PD-L1 negative NSCLC, all patients with NSCLC

  8. To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Proportion of patients alive and progression free at 12 months (APF12) [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    bTMB defined populations, PD-L1 negative NSCLC, all patients with NSCLC

  9. To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Progression-free survival after subsequent anticancer therapy (PFS2) [ Time Frame: Up to 4 years 6 months after first patient randomized' ]
    bTMB defined populations, PD-L1 negative NSCLC, all patients with NSCLC

  10. To assess efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of ORR in further PD-L1 defined populations [ Time Frame: Up to 4 years 6 months after first patient randomized ]
  11. To assess efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of PFS in further PD-L1 defined populations [ Time Frame: Up to 4 years 6 months after first patient randomized ]
  12. To assess efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of OS in further PD-L1 defined populations [ Time Frame: Up to 4 years 6 months after first patient randomized ]
  13. To further assess efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of ORR [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    tTMB defined populations

  14. To further assess efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of PFS [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    tTMB defined populations

  15. To further assess efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of OS [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    tTMB defined populations

  16. To assess the pharmacokinetics (PK) of MEDI4736 + tremelimumab combination therapy [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    Serum concentration of MEDI4736 and tremelimumab

  17. To investigate the immunogenicity of MEDI4736 and tremelimumab [ Time Frame: Up to 4 years 6 months after first patient randomized ]
    Detection of the presence of anti-drug antibodies for MEDI4736 and tremelimumab


Other Outcome Measures:
  1. To assess the number of Treatment-Related Adverse Events as assessed by CTCAE v4.03 for patients receiving durvalumab + tremelimumab combination therapy or SoC. [ Time Frame: Up to 4 years 6 months after first patient randomized ]


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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:

  • Aged at least 18 years
  • Documented evidence of Stage IV NSCLC
  • No activating EGFR mutation or ALK rearrangement
  • No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
  • World Health Organization (WHO) Performance Status of 0 or 1
  • No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, 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
  • Brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment.
  • Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)

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): NCT02542293


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Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Gilberto de Castro Faculdade de Medicina da Universidade de São Paulo

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02542293     History of Changes
Other Study ID Numbers: D419AC00003
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

Keywords provided by AstraZeneca:
NSCLC
PDL1
TMB
MEDI4736
Durvalumab
Tremelimumab
OS

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Gemcitabine
Carboplatin
Pemetrexed
Durvalumab
Tremelimumab
Antineoplastic Agents
Antibodies, Monoclonal
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