Clinical trial · Interventional
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Carcinoma NSCLC | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab +Tremelimumab | Biological | Durvalumab/Tremelimumab Regimen | ALIAS |
| Gemcitabine + carboplatin | Drug | — | UNRESOLVED |
| Gemcitabine + cisplatin | Drug | — | UNRESOLVED |
| Paclitaxel + carboplatin | Drug | Carboplatin/Paclitaxel Regimen | ALIAS |
| Pemetrexed + carboplatin | Drug | — | UNRESOLVED |
| Pemetrexed + cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combination Therapy
- description
- Durvalumab (PD-L1 monoclonal antibody) + Tremelimumab (monoclonal antibody directed against CTLA-4)
- interventionNames
- Biological: Durvalumab +Tremelimumab
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- Standard of Care chemotherapy treatment
- interventionNames
- Drug: Paclitaxel + carboplatin
- Drug: Gemcitabine + cisplatin
- Drug: Gemcitabine + carboplatin
- Drug: Pemetrexed + cisplatin
- Drug: Pemetrexed + carboplatin
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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: 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)
References
Publications (1)
- DERIVEDCheng Y, Zhou Q, Han B, Fan Y, Shan L, Chang J, Sun S, Fang J, Chen Y, Sun J, Wu G, Mann H, Naicker K, Shire N, Mok T, de Castro G Jr. NEPTUNE China cohort: First-line durvalumab plus tremelimumab in Chinese patients with metastatic non-small-cell lung cancer. Lung Cancer. 2023 Apr;178:87-95. doi: 10.1016/j.lungcan.2023.01.013. Epub 2023 Feb 1. PMID 36806898