Study of Durvalumab with Tremelimumab versus SoC as 1st line therapy in metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE) - NEPTUNE

Study identifier:D419AC00003

ClinicalTrials.gov identifier:NCT02542293

EudraCT identifier:2015-002197-21

CTIS identifier:N/A

Recruitment Complete

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).

Medical condition

Non Small Cell Lung Carcinoma NSCLC

Phase

Phase 3

Healthy volunteers

Study drug

Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin, Pemetrexed + carboplatin

Sex

All

Actual Enrollment

953

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 03 Nov 2015

Primary Completion Date: 21 Sept 2020

Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
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	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

Arms

Assigned Interventions

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

Drug: Paclitaxel + carboplatin
Chemotherapy Agents