NEPTUNE.

Study name	Study of 1st line therapy study of durvalumab with tremelimumab versus SoC in Non Small‐Cell Lung Cancer (NSCLC) (NEPTUNE).
Methods	Open‐label, multicentre, Phase 3 RCT
Participants	953 participants NCT03191786 Inclusion 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 (e.g., Crohn's disease, ulcerative colitis)
Interventions	Intervention Durvalumab (PD‐L1 monoclonal antibody) + Tremelimumab (monoclonal antibody directed against CTLA‐4) Comparator: Standard of Care chemotherapy treatment
Outcomes	Primary outcomes Overall survival (OS), time frame up to 4 years after first patient randomised Secondary outcomes: OS in patients with PD‐L1‐negative NSCLC, time Frame: up to 4 years after first patient randomised Progression‐free survival (PFS), time Frame: up to 4 years after first patient randomised Objective response rate (ORR), Time Frame: up to 4 years after first patient randomised Duration of response (DoR) Proportion of patients alive at 18 months (OS18) Proportion of patients alive and progression free at 12 months (APF12) Progression‐free survival after subsequent anticancer therapy (PFS2). PK parameters Measuring the immunogenicity of durvalumab and tremelimumab by measuring the presence of Anti‐drug Antibodies Proportion of patients alive at 12 months (OS12). Other outcomes Treatment‐related adverse events as assessed by CTCAE v4.03
Starting date	November 3, 2015 Estimated study completion date: August 22, 2019
Contact information
Notes	ClinicalTrials.gov Identifier: NCT02542293