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

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Non Small Cell Lung Carcinoma NSCLC

Treatments: Drug: Gemcitabine + carboplatin; Biological: Durvalumab +Tremelimumab; Drug: Gemcitabine + cisplatin; Drug: Paclitaxel + carboplatin; Drug: Pemetrexed + cisplatin; Drug: Pemetrexed + carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02542293

2015-002197-21 (EudraCT Number)

D419AC00003

Details and patient eligibility

About

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.

Full description

Patients will be randomized in a 1:1 to receive treatment with durvalumab + tremelimumab combination therapy or SoC therapy. The primary objective of this study is to assess the efficacy of combination treatment compared with SoC in terms of Overall Survival (OS) in patients.

Enrollment: 953 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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953 participants in 2 patient groups

Combination Therapy

Experimental group

Description:

Durvalumab (PD-L1 monoclonal antibody) + Tremelimumab (monoclonal antibody directed against CTLA-4)

Treatment:

Biological: Durvalumab +Tremelimumab

Standard of Care

Active Comparator group

Description:

Standard of Care chemotherapy treatment

Treatment:

Drug: Pemetrexed + carboplatin

Drug: Pemetrexed + cisplatin

Drug: Paclitaxel + carboplatin

Drug: Gemcitabine + cisplatin

Drug: Gemcitabine + carboplatin