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

No Placebo-Only Group

Pivotal 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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Other study objectives

To assess the number of Treatment-Related Adverse Events as assessed by CTCAE v4.03 for patients receiving durvalumab + tremelimumab combination therapy or SoC.