Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE).

• Status: Active, not recruiting
• Trial end date: 2021-10-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Antibodies, Monoclonal; Antineoplastic Agents; Carboplatin; Cisplatin; Durvalumab; Gemcitabine; Paclitaxel; Pemetrexed; Tremelimumab

Criteria

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)