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