MedTrace Logo

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

NCT02542293 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 953

Last updated 2026-05-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Non Small Cell Lung Carcinoma NSCLC

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Gilberto de Castro · Faculdade de Medicina da Universidade de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-03
Primary Completion
2020-09-21
Completion
2026-12-31

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02542293 on ClinicalTrials.gov