A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Conditions

• Non - Small Cell Lung Cancer NSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• MEDI4736 (durvalumab) — DRUG
  MEDI4736 (durvalumab) treatment by intravenous infusion
• Vinorelbine — DRUG
  Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.
• Gemcitabine — DRUG
  Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
• Erlotinib — DRUG
  Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration
• MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) — DRUG
  MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion
• tremelimumab (anti-CTLA4) — DRUG
  tremelimumab (anti-CTLA4) treatment by intravenous infusion

Study Details

This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib \[TARCEVA®\]), gemcitabine or vinorelbine (NAVELBINE®)

Key Dates

Start date

Jan 13, 2015

Status verified

Jul 2024

Primary completion

Feb 9, 2018

Completion

Aug 30, 2023

Study Design

Enrollment

597 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MEDI4736 (durvalumab) monotherapy in Sub-study A
  MEDI4736 (durvalumab) by intravenous infusion. Sub-study A for patients with PD-L1 positive tumors.
• Active Comparator: Standard of Care in Sub-study A
  Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study A for patients with PD-L1 positive tumors.
• Experimental: MEDI4736 (durvalumab) + tremelimumab in Sub-study B
  MEDI4736 (durvalumab) by intravenous infusion and tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.
• Active Comparator: Standard of Care in Sub-study B
  Investigator choice from Vinorelbine, Gemcitabine and Erlotinib. Sub-study B for patients with PD-L1 negative tumors.
• Experimental: MEDI4736 (durvalumab) monotherapy in Sub-study B
  MEDI4736 (durvalumab) by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.
• Experimental: tremelimumab in Sub-study B
  tremelimumab by intravenous infusion. Sub-study B for patients with PD-L1 negative tumors.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomization (Day 1) until death due to any cause, approximately 36 months ]

Locations (33)

Find similar trials in Chandler, AZ