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Активно (без набиране) Фаза 2 NCT04736173

Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Non Small Cell Lung Cancer Nonsquamous Non Small Cell Lung Cancer Squamous Non Small Cell Lung Cancer Lung Cancer

Спонсор: Arcus Biosciences, Inc.

Налично на: БГ
Обобщение
This is a phase 2 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) in front-line, PD-L1-high, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC).
Кой може да участва
Key Inclusion Criteria: * Histologically confirmed, treatment naïve, locally advanced or metastatic (stage IIIB IV per AJCC version 8), squamous or non-squamous NSCLC with documented high PD L1 expression (TC ≥ 50%) as determined by the VENTANA SP263 IHC assay, as assessed by central laboratories). * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Must have at least 1 measurable lesion per RECIST v1.1 * Adequate organ and marrow function * If a participant has brain or meningeal metastases, the participant must meet the following criteria: 1. Have no evidence of progression by neurologic symptoms or signs for at least 4 weeks prior to the first dose. 2. Participants with previously treated brain metastases may participate provided they have stable central nervous system (CNS) disease for at least 4 weeks prior to enrollment. Stable CNS disease is defined as resolution of all neurologic symptoms to baseline, having no evidence of new or enlarging brain metastases, and not requiring use of corticosteroids for CNS disease for at least 14 days prior to the start of study treatment. Participants who have had brain metastases resected or have received whole brain radiotherapy ending at least 4 weeks (or stereotactic radiotherapy ending at least 2 weeks) prior to initiation of study treatment are permitted. 3. Carcinomatous meningitis is excluded regardless of clinical stability. Key Exclusion Criteria: * Presence of any tumor genomic aberration or driver mutation for which a targeted therapy is approved by local health authority and available * Use of any live vaccines against infectious diseases within 28 days of first dose * Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy. * Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer * Prior treatment with any anti-PD-1, anti-PD-L1 or any other antibody targeting an immune checkpoint. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Интервенции
Domvanalimab
DRUG
Zimberelimab
DRUG
Carboplatin
DRUG
Paclitaxel
DRUG
Pemetrexed
DRUG
Pembrolizumab
DRUG
Места на провеждане 39
Hong Kong (1)
Research Site
Hong Kong
Malaysia (6)
Research Site
Johor Bahru
Research Site
Kuala Lumpur
Research Site
Kuantan
Research Site
Kuching
Research Site
Pulau Pinang
Research Site
Putrajaya
Philippines (2)
Research Site
Davao City
Research Site
Manila
South Africa (3)
Research Site
George
Research Site
Johannesburg
Research Site
Pretoria
Южна Корея (5)
Research Site
Daegu
Research Site
Incheon
Research Site
Jinju
Research Site
Seoul
Research Site
Suwon
Taiwan (1)
Research Site
Taichung
Тайланд (11)
Research Site
Bangkok
Research Site
Changwat Sara Buri
Research Site
Chanthaburi
Research Site
Chiang Mai
Research Site
Khon Kaen
Research Site
Lampang
Research Site
Nakhon Nayok
Research Site
Nakhon Ratchasima
Research Site
Phitsanulok
Research Site
Songkhla
Research Site
Ubon Ratchathani
Турция (5)
Research Site
Adana
Research Site
Ankara
Research Site
Edirne
Research Site
Istanbul
Research Site
Kocaeli
САЩ (3)
Research Site
Blacksburg , Virginia
Research Site
Columbus , Georgia
Research Site
Kingwood , Texas
Vietnam (2)
Research Site
Hanoi
Research Site
Huế
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
08.02.2021
Крайна дата
01.05.2027
Регистрационен номер
NCT04736173
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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