NCT02542293

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

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).

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 953 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Non Small Cell Lung Carcinoma NSCLC

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab +Tremelimumab
DRUG	Paclitaxel + carboplatin	Chemotherapy Agents
DRUG	Gemcitabine + cisplatin	Chemotherapy Agents
DRUG	Gemcitabine + carboplatin	Chemotherapy Agents
DRUG	Pemetrexed + cisplatin	Chemotherapy Agent
DRUG	Pemetrexed + carboplatin	Chemotherapy Agent

Timeline

• Start date: 2015-11-03
• Primary completion: 2020-09-21
• Completion: 2026-12-31
• First posted: 2015-09-07
• Last updated: 2026-02-12
• Results posted: 2022-05-24

Locations

210 sites across 29 countries: United States, Argentina, Brazil, Bulgaria, Chile, China, Denmark, Finland, Greece, Hong Kong, India, Israel, Japan, Malaysia, Mexico, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Sweden, Turkey (Türkiye), Ukraine, United Kingdom