Durvalumab + Tremelimumab for Non-Small Cell Lung Cancer
(NEPTUNE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on steroids for brain metastases, you must be off them for at least 14 days before starting the study treatment.
Is the combination of Durvalumab and Tremelimumab safe for humans?
The combination of Durvalumab and Tremelimumab has been studied in various cancers and generally shows a tolerable safety profile, but it can cause side effects like diarrhea, skin issues, and thyroid problems. Serious side effects, though less common, include inflammation of the lungs (pneumonitis) and heart (myocarditis), and there have been some treatment-related deaths.12345
How is the drug combination of Durvalumab and Tremelimumab unique for treating non-small cell lung cancer?
The combination of Durvalumab and Tremelimumab is unique because it uses two types of immune checkpoint inhibitors (drugs that help the immune system attack cancer cells) together with chemotherapy, which has been shown to significantly improve survival in patients with metastatic non-small cell lung cancer compared to chemotherapy alone.36789
What data supports the effectiveness of the drug combination Durvalumab + Tremelimumab for treating non-small cell lung cancer?
Who Is on the Research Team?
Gilberto de Castro
Principal Investigator
Faculdade de Medicina da Universidade de São Paulo
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced NSCLC who haven't had chemotherapy or immune therapy before. They should be in good physical condition and not have certain gene mutations (EGFR, ALK). People with mixed small cell lung cancer, autoimmune diseases like Crohn's, or unstable brain metastases can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive durvalumab + tremelimumab combination therapy or standard of care chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab + Tremelimumab
- Gemcitabine + Carboplatin
- Gemcitabine + Cisplatin
- Paclitaxel + Carboplatin
- Pemetrexed + Carboplatin
- Pemetrexed + Cisplatin
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology