Study to Evaluate Monotherapy Compared to Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer

Ведущий спонсор: Arcus Biosciences, Inc.

This Randomized Phase 3 Open-label Study will Evaluate the Efficacy of Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined with AB154 in Front-Line, PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

• Non Small Cell Lung Cancer
• Nonsquamous Non Small Cell Lung Cancer
• Squamous Non-small-cell Lung Cancer
• Lung Cancer

Тип вмешательства: Drug

Название вмешательства: Zimberelimab

Описание: Zimberelimab is a fully human anti-PD-1 monoclonal antibody

Другое имя: AB122

Тип вмешательства: Drug

Название вмешательства: Domvanalimab

Описание: Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

Этикетка Arm Group: Arm C (Zimberelimab + AB154 Combination Therapy)

Другое имя: AB154

Тип вмешательства: Drug

Название вмешательства: Carboplatin

Описание: Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Этикетка Arm Group: Arm A (Platinum-based Chemotherapy)

Тип вмешательства: Drug

Название вмешательства: Pemetrexed

Описание: Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Этикетка Arm Group: Arm A (Platinum-based Chemotherapy)

Тип вмешательства: Drug

Название вмешательства: Paclitaxel

Описание: Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.

Этикетка Arm Group: Arm A (Platinum-based Chemotherapy)

Критерии:

Inclusion Criteria: - Histologically confirmed, squamous or nonsquamous, treatment-naive PD-L1 positive, NSCLC that is locally advanced or metastatic without sensitizing epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation - 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 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.

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

No

Фамилия: Medical Director

Телефон: 510-694-6220

Bangladesh

Belarus

Brazil

Egypt

Greece

Hong Kong

India

Korea, Republic of

Malaysia

Mexico

Peru

Philippines

Russian Federation

Serbia

Slovakia

South Africa

Taiwan

Thailand

Turkey

Ukraine

Vietnam

2022-02-01

Тип: Sponsor

• Non Small Cell Lung Cancer
• Lung Cancer
• NSCLC

• Lung Neoplasms
• Carcinoma, Non-Small-Cell Lung

Метка: Arm A (Platinum-based Chemotherapy)

Тип: Active Comparator

Описание: Participants will receive carboplatin, pemetrexed, and paclitaxel by intravenous (IV) infusion.

Метка: Arm B (Zimberelimab Monotherapy)

Тип: Experimental

Описание: Participants will receive zimberelimab monotherapy by IV infusion.

Метка: Arm C (Zimberelimab + AB154 Combination Therapy)

Тип: Active Comparator

Описание: Participants will receive zimberelimab in combination with AB154 by IV infusion.

Распределение: Randomized

Модель вмешательства: Parallel Assignment

Первичное назначение: Treatment

Маскировка: None (Open Label)