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

This study is currently recruiting participants.
Verified November 2017 by AstraZeneca
Sponsor:
ClinicalTrials.gov Identifier:
NCT02542293
First Posted: September 7, 2015
Last Update Posted: November 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the efficacy of durvalumab + tremelimumab combintion therapy compared to Standard of Care (SoC) in terms of Overall Survival (OS) in patients with Non-small-cell lung cancer (NSCLC) [ Time Frame: Up to 4 years after first patient randomized ]
    Assess the Overall Survival


Secondary Outcome Measures:
  • To assess the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of OS in patients with PD-L1-negative NSCLC [ Time Frame: Up to 4 years after first patient randomized ]
  • To further assess the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Progression-free survival (PFS). [ Time Frame: Up to 4 years after first patient randomized ]
  • To further assess the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Objective response rate (ORR). [ Time Frame: Up to 4 years after first patient randomized ]
  • To further assess the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Duration of response (DoR). [ Time Frame: Up to 4 years after first patient randomized ]
  • To further assess the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Proportion of patients alive at 18 months (OS18). [ Time Frame: Up to 4 years after first patient randomized ]
  • To further assess the efficacy of durvalumab + 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 after first patient randomized ]
  • To further assess the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Progression-free survival after subsequent anticancer therapy (PFS2). [ Time Frame: Up to 4 years after first patient randomized' ]
  • To assess the PK paramenters of durvalumab + tremelimumab combination therapy by measuring the concentration in blood and non compartmental PK parameters such as peak concentration and trough [ Time Frame: Up to 4 years after first patient randomized ]
  • To investigate the immunogenicity of durvalumab and tremelimumab by measuring the presence of Anti-drug Antibodies (confirmatory results: positive and negative; titers) [ Time Frame: Up to 4 years after first patient randomized ]
  • To further assess the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of Proportion of patients alive at 12 months (OS12). [ Time Frame: Up to 4 years after first patient randomized ]

Other Outcome Measures:
  • 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 after first patient randomized ]

Estimated Enrollment: 960
Actual Study Start Date: November 3, 2015
Estimated Study Completion Date: October 4, 2018
Estimated Primary Completion Date: October 4, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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.


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
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 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 inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
  Contacts and Locations
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


Contacts
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

  Show 294 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Leonardo Trani AstraZeneca, Cambridge Science Park, US
Principal Investigator: Tony Mok The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT, Hong Kong
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02542293     History of Changes
Other Study ID Numbers: D419AC00003
First Submitted: August 26, 2015
First Posted: September 7, 2015
Last Update Posted: November 8, 2017
Last Verified: November 2017

Keywords provided by AstraZeneca:
NSCLC
PDL1
MEDI4736
Durvalumab
Tremelimumab
OS

Additional relevant MeSH terms:
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
Gemcitabine
Tremelimumab
Cisplatin
Carboplatin
Pemetrexed
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