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Checkpoint Inhibitor
Durvalumab + Tremelimumab for Non-Small Cell Lung Cancer (NEPTUNE Trial)
Phase 3
Waitlist Available
Led By Gilberto de Castro
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose and within 1 hour after end of infusion at week 0 and 12; pre-dose on week 24 and at follow-up month 3
Awards & highlights
NEPTUNE Trial Summary
This trial is testing a new combination therapy for patients with advanced lung cancer who have not yet been treated. The new therapy combines two drugs, durvalumab and tremelimumab. The trial will compare this new therapy to standard chemotherapy to see if it is more effective and has fewer side effects.
Who is the study for?
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.Check my eligibility
What is being tested?
The study compares a combination of two immunotherapy drugs (Durvalumab + Tremelimumab) against standard platinum-based chemotherapy as the first treatment for patients with NSCLC. It's randomized and open-label, meaning neither the researchers nor participants are blinded to which group they're in.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect organs, infusion reactions similar to allergic responses during drug administration, fatigue, and potential worsening of pre-existing autoimmune conditions.
NEPTUNE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-dose and within 1 hour after end of infusion at week 0 and 12; pre-dose on week 24 and at follow-up month 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose and within 1 hour after end of infusion at week 0 and 12; pre-dose on week 24 and at follow-up month 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set
Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set
Secondary outcome measures
Folic acid
Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets
DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets
+15 moreOther outcome measures
To assess the number of Treatment-Related Adverse Events as assessed by CTCAE v4.03 for patients receiving durvalumab + tremelimumab combination therapy or SoC.
NEPTUNE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Combination TherapyExperimental Treatment1 Intervention
Durvalumab (PD-L1 monoclonal antibody) + Tremelimumab (monoclonal antibody directed against CTLA-4)
Group II: Standard of CareActive Control5 Interventions
Standard of Care chemotherapy treatment
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,287 Previous Clinical Trials
288,619,197 Total Patients Enrolled
Gilberto de CastroPrincipal InvestigatorFaculdade de Medicina da Universidade de São Paulo
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't received any treatment for my recurrent or metastatic NSCLC.I have stable brain metastases and haven't taken steroids for 14 days.My lung cancer is a mix of small cell and non-small cell types.I have never received immune therapy for cancer, except for cancer vaccines.I am fully active or able to carry out light work.I am 18 years old or older.I have or had an autoimmune or inflammatory disorder like Crohn's disease.My condition is Stage IV non-small cell lung cancer.My cancer does not have EGFR mutations or ALK rearrangements.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy
- Group 2: Standard of Care
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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