Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
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.
Checked against the public recordLast updated Aug 6, 2026 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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 Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: * Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant * Brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment. * Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.