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

NCT02542293

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Non Small Cell Lung Carcinoma NSCLC

Interventions: Durvalumab +Tremelimumab, Paclitaxel + carboplatin, Gemcitabine + cisplatin, Gemcitabine + carboplatin, Pemetrexed + cisplatin

Countries: United States, Argentina, Brazil, Bulgaria, Chile, China, Denmark, Finland

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 overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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)
Locations (210)
  • Anaheim, California, United States
  • San Diego, California, United States
  • Santa Rosa, California, United States
  • Louisville, Kentucky, United States
  • Florham Park, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • East Setauket, New York, United States
  • Fresh Meadows, New York, United States
  • Poughkeepsie, New York, United States
  • Stony Brook, New York, United States
  • Canton, Ohio, United States
  • Columbus, Ohio, United States
  • Zanesville, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Houston, Texas, United States
  • Berazategui, Argentina
  • CABA, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Córdoba, Argentina
  • La Rioja, Argentina
  • Rosario, Argentina
  • San Salvador de Jujuy, Argentina
  • Santa Rosa, Argentina
  • Barretos, Brazil
  • Belo Horizonte, Brazil
  • Belo Horizonte, Brazil
  • Fortaleza, Brazil
  • Ijuí, Brazil
  • Itajaí, Brazil
  • Porto Alegre, Brazil
  • + 180 more on CT.gov