Active Not RecruitingPhase 3NCT02542293
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDurvalumab +Tremelimumab and Paclitaxel + carboplatin

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 6, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?210 U.S. locations

Locations may change over time.

Who runs it?AstraZeneca

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
AstraZeneca
Interventions being studied
Biological: Durvalumab +Tremelimumab; Drug: Paclitaxel + carboplatin; Drug: Gemcitabine + cisplatin; Drug: Gemcitabine + carboplatin; Drug: Pemetrexed + cisplatin; Drug: Pemetrexed + carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • For inclusion in the study, patients should fulfill the following criteria:
  • Aged at least 18 years
  • Documented evidence of Stage IV NSCLC
  • No activating EGFR mutation or ALK rearrangement
  • No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
  • World Health Organization (WHO) Performance Status of 0 or 1
  • No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, excluding therapeutic anticancer vaccines
Reasons someone may not be able to joinExclusion criteria

Patients should not enter the study if any of the following

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteAnaheim, California
  • Research SiteSan Diego, California
  • Research SiteSanta Rosa, California
  • Research SiteLouisville, Kentucky
  • Research SiteFlorham Park, New Jersey
  • Research SiteAlbuquerque, New Mexico
  • Research SiteEast Setauket, New York
  • Research SiteFresh Meadows, New York
  • Research SitePoughkeepsie, New York
  • Research SiteStony Brook, New York
  • Research SiteCanton, Ohio
  • Research SiteColumbus, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 6, 2026. Always confirm current availability with the study team.

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