NCT02542293|Active Not RecruitingPhase 3ResultsDMC

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

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).

AstraZeneca ClinicalTrials.gov

Compare

2 other identifiers

D419AC000032015-002197-21

Study Type

interventional

Target

953

Locations

29 countries

Sites

210

Timeline

RegisteredSep 2015

StartedNov 2015

CompletionDec 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

953

participants targeted

Target at P75+ for phase_3

Timeline

8mo left

Started Nov 2015

Longer than P75 for phase_3

Geographic Reach

29 countries

210 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11.2 years study duration

Study Progress94%

Nov 2015Dec 2026

First Submitted

Initial submission to the registry

August 26, 2015

Completed

12 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed

2 months until next milestone

Study Start

First participant enrolled

November 3, 2015

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2020

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

May 24, 2022

Completed

4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.9 years

First QC Date

August 26, 2015

Results QC Date

September 20, 2021

Last Update Submit

April 30, 2026

Conditions

Non Small Cell Lung Carcinoma NSCLC

Keywords

NSCLCPDL1TMBMEDI4736DurvalumabTremelimumabOS

Outcome Measures

Primary Outcomes (2)

Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
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).
OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months).

Secondary Outcomes (18)

OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets
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).
OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets
From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global or China cohort DCO dates, as applicable (a maximum of approximately 44 months) for each cohort.
Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets
Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).
PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets
Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.
Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets
Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).
+13 more secondary outcomes

Study Arms (2)

Combination Therapy

EXPERIMENTAL

Durvalumab (PD-L1 monoclonal antibody) + Tremelimumab (monoclonal antibody directed against CTLA-4)

Biological: Durvalumab +Tremelimumab

Standard of Care

ACTIVE COMPARATOR

Standard of Care chemotherapy treatment

Drug: Paclitaxel + carboplatinDrug: Gemcitabine + cisplatinDrug: Gemcitabine + carboplatinDrug: Pemetrexed + cisplatinDrug: Pemetrexed + carboplatin

Interventions

Durvalumab +TremelimumabBIOLOGICAL

Combination Therapy

Paclitaxel + carboplatinDRUG

Chemotherapy Agents