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

Running, not enrolling · Phase 3

Conditions studied: Non Small Cell Lung Carcinoma NSCLC

In brief

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.

Key facts

Study ID

NCT02542293

Run by

AstraZeneca

People needed

953

Starts

2015-11-03

Expected to finish

2026-12-31

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Research Site — San Diego, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Florham Park, New Jersey, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — East Setauket, New York, United States
• Research Site — Fresh Meadows, New York, United States
• Research Site — Poughkeepsie, New York, United States
• Research Site — Stony Brook, New York, United States
• Research Site — Canton, Ohio, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Zanesville, Ohio, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Houston, Texas, United States
• Research Site — Berazategui, Argentina
• Research Site — CABA, Argentina
• Research Site — Ciudad de Buenos Aires, Argentina
• Research Site — Córdoba, Argentina
• Research Site — La Rioja, Argentina
• Research Site — Rosario, Argentina
• Research Site — San Salvador de Jujuy, Argentina
• Research Site — Santa Rosa, Argentina
• Research Site — Barretos, Brazil
• Research Site — Belo Horizonte, Brazil
• Research Site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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