For Healthcare Professionals

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

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About the study

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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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


For inclusion in the study, patients should fulfill the following criteria:


  1. Aged at least 18 years
  2. Documented evidence of Stage IV NSCLC
  3. No activating EGFR mutation or ALK rearrangement
  4. No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC
  5. World Health Organization (WHO) Performance Status of 0 or 1
  6. 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

Exclusion Criteria:


Patients should not enter the study if any of the following exclusion criteria are fulfilled:


  1. Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant
  2. 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.
  3. Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Non Small Cell Lung Carcinoma NSCLC

Age (in years)

18 - 130

Phase

Phase 3

Participants needed

953

Est. Completion Date

Dec 29, 2023

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT02542293

Study number

D419AC00003

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