Lung Cancer, Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer
Conditions
Keywords
Domvanalimab, Zimberelimab, Non Small Cell Lung Cancer, Lung Cancer, NSCLC
Brief summary
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).
Interventions
DRUGDomvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
DRUGZimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
DRUGCarboplatin
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
DRUGPaclitaxel
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
DRUGPemetrexed
Participants receive carboplatin, pemetrexed, and paclitaxel at a target area under the curve.
DRUGPembrolizumab
Pembrolizumab is a humanized Immunoglobulin G4 monoclonal antibody targeting the PD-1 receptor
Sponsors
Arcus Biosciences, Inc.
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) | From randomization until death from any cause (up to 7 years) |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With treatment-emergent adverse events | From randomization until death from any cause (up to 7 years) |
| Confirmed Overall Response Rate (ORR) | From randomization until death from any cause (up to 7 years) |
| Overall Survival (OS) | From randomization until death from any cause (up to 7 years) |
Countries
Hong Kong, Malaysia, Philippines, South Africa, South Korea, Taiwan, Thailand, Turkey (Türkiye), United States, Vietnam
Contacts
STUDY_DIRECTORMedical Director
Arcus Biosciences, Inc.
Outcome results
None listed