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Clinical Trials in Turkey / NCT02542293
Active, not recruiting Phase 3

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

NCT02542293 · tracked via the Priya Life Science Turkey tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2015-11-03
Last updated
2026-08-06

Condition(s) studied

Non Small Cell Lung Carcinoma NSCLC

Investigational drug(s) / intervention(s)

Durvalumab +TremelimumabAll Durvalumab trials (217) →All Tremelimumab trials (47) →Paclitaxel + carboplatinAll Paclitaxel trials (424) →All Carboplatin trials (587) →Gemcitabine + cisplatinAll Gemcitabine trials (386) →All Cisplatin trials (506) →Gemcitabine + carboplatinAll Gemcitabine trials (386) →All Carboplatin trials (587) →Pemetrexed + cisplatinAll Pemetrexed trials (246) →All Cisplatin trials (506) →Pemetrexed + carboplatinAll Pemetrexed trials (246) →All Carboplatin trials (587) →

Paclitaxel + carboplatin: Chemotherapy Agents

Gemcitabine + cisplatin: Chemotherapy Agents

Gemcitabine + carboplatin: Chemotherapy Agents

Pemetrexed + cisplatin: Chemotherapy Agent

Pemetrexed + carboplatin: Chemotherapy Agent

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set — From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).
    The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
  • OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set — From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months).
    The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

Trial sites (210)

FacilityCityRegionStatus
Research Site Anaheim California
Research Site San Diego California
Research Site Santa Rosa California
Research Site Louisville Kentucky
Research Site Florham Park New Jersey
Research Site Albuquerque New Mexico
Research Site East Setauket New York
Research Site Fresh Meadows New York
Research Site Poughkeepsie New York
Research Site Stony Brook New York
Research Site Canton Ohio
Research Site Columbus Ohio
Research Site Zanesville Ohio
Research Site Pittsburgh Pennsylvania
Research Site Houston Texas
Research Site Berazategui Argentina
Research Site CABA Argentina
Research Site Ciudad de Buenos Aires Argentina
Research Site Córdoba Argentina
Research Site La Rioja Argentina
Research Site Rosario Argentina
Research Site San Salvador de Jujuy Argentina
Research Site Santa Rosa Argentina
Research Site Barretos Brazil
Research Site Belo Horizonte Brazil
Research Site Belo Horizonte Brazil
Research Site Fortaleza Brazil
Research Site Ijuí Brazil
Research Site Itajaí Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site São José do Rio Preto Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Plovdiv Bulgaria
Research Site Shumen Bulgaria
Research Site Sofia Bulgaria

+ 170 more sites — see the full list on the official registry below.

More AstraZeneca trials in Turkey

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer Active, not recruiting
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors Recruiting
A Study of Rilvegostomig or Durvalumab Plus Chemotherapy for First-Line Treatment of Biliary Tract Cancer (ARTEMIDE-Biliary02) Recruiting

Other trials for the same condition

Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02542293 on ClinicalTrials.gov ↗ ← All trials in Turkey