NEPTUNE

A Phase 3 Randomized, Open-Label, Multi-Center, Global Study of Durvalumab in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223156

Enrollment

Registered

2016-04-01

Start date

2016-04-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Carcinoma (NSCLC)

Interventions

investigational material(s) Generic name etc : Durvalumab+Tremelimumab, Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin, Pemetrexed + carboplatin I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For inclusion in the study, patients should fulfill the following criteria: - 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 smallcell 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 (e.g., Crohn's disease, ulcerative colitis)

Design outcomes

Primary

Measure	Time frame
efficacy -	—

Secondary

Measure	Time frame
safety confirmatory exploratory pharmacokinetics pharmacogenomics -	—

Countries

-, Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026