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

Conditions

• Non Small Cell Lung Carcinoma NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab +Tremelimumab — BIOLOGICAL
• Paclitaxel + carboplatin — DRUG
  Chemotherapy Agents
• Gemcitabine + cisplatin — DRUG
  Chemotherapy Agents
• Gemcitabine + carboplatin — DRUG
  Chemotherapy Agents
• Pemetrexed + cisplatin — DRUG
  Chemotherapy Agent
• Pemetrexed + carboplatin — DRUG
  Chemotherapy Agent

Study Details

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.

Key Dates

Start date

Nov 3, 2015

Status verified

Apr 2026

Primary completion

Sep 21, 2020

Completion

Dec 31, 2026

Study Design

Enrollment

953 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Combination Therapy
  Durvalumab (PD-L1 monoclonal antibody) + Tremelimumab (monoclonal antibody directed against CTLA-4)
• Active Comparator: Standard of Care
  Standard of Care chemotherapy treatment

Primary Outcome Measure

Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set [ Time Frame: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months). ]

Locations (15)

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