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2N-15-11-A Phase 3 Randomized, Open Label, Multi-Center, Global Study of MEDI4736 in combination with Tremelimumab Therapy vs Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic Non-Small-Cell Lung cancer (NSCLC) (NEPTUNE)

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.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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 IMT, including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, excluding therapeutic anticancer vaccines

  • 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 inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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