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Активно (без набиране) Фаза 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)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Non-Small-Cell Lung Carcinoma NSCLC

Спонсор: AstraZeneca

Налично на: БГ
Обобщение
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
Описание
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.
Кой може да участва
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 \[eg, colitis or Crohn's disease\]
Места на провеждане 17
Австралия (1)
Research Site
Box Hill
Белгия (1)
Research Site
Brussels
Канада (1)
Research Site
Greater Sudbury , Ontario
Франция (1)
Research Site
Bordeaux
Германия (1)
Research Site
Aachen
Унгария (1)
Research Site
Budapest
Италия (1)
Research Site
Genova
Япония (1)
Research Site
Fukushima
Нидерландия (1)
Research Site
's-Hertogenbosch
Russia (1)
Research Site
Moscow
Южна Корея (1)
Research Site
Busan
Испания (1)
Research Site
A Coruña
Швейцария (1)
Research Site
Bellinzona
Taiwan (1)
Research Site
Kaohsiung City
Тайланд (1)
Research Site
Bangkok
САЩ (1)
Research Site
Scottsdale , Arizona
Vietnam (1)
Research Site
Hanoi
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
130 Years
Здрави доброволци
Не
Начална дата
21.07.2015
Крайна дата
31.12.2026
Регистрационен номер
NCT02453282
Източник
anzctr
Запитване за медицински туризъм

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