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Active (not recruiting) Phase 3 NCT02453282

Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)

Phase 3 – large-scale trial before approval
Conditions: Non-Small-Cell Lung Carcinoma NSCLC

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy 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 locally advanced or metastatic NSCLC
Description
Patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or Standard of Care (SoC) therapy.
Who can participate
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 sensitizing 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 Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant 2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) 3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\]
Locations 17
Australia (1)
Research Site
Box Hill
Belgium (1)
Research Site
Brussels
Canada (1)
Research Site
Greater Sudbury , Ontario
France (1)
Research Site
Bordeaux
Germany (1)
Research Site
Aachen
Hungary (1)
Research Site
Budapest
Italy (1)
Research Site
Genova
Japan (1)
Research Site
Fukushima
Netherlands (1)
Research Site
's-Hertogenbosch
Russia (1)
Research Site
Moscow
South Korea (1)
Research Site
Busan
Spain (1)
Research Site
A Coruña
Switzerland (1)
Research Site
Bellinzona
Taiwan (1)
Research Site
Kaohsiung City
Thailand (1)
Research Site
Bangkok
United States (1)
Research Site
Scottsdale , Arizona
Vietnam (1)
Research Site
Hanoi
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No
Start date
21.07.2015
Completion date
31.12.2026
Registry ID
NCT02453282
Source
anzctr
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