Advanced Non-Small Cell Lung Cancer
Conditions
Keywords
Advanced Non-Small Cell Lung Cancer, Domvanalimab, Zimberelimab, Quemliclustat, Anti-TIGIT antibody, Anti-PD-1 antibody
Brief summary
The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.
Detailed description
The study includes multiple substudy arms (Substudy A, B, C), which will evaluate immunotherapy-based combinations.
Interventions
DRUGDomvanalimab
Administered as specified in the treatment arm
DRUGQuemliclustat
Administered as specified in the treatment arm
DRUGZimberelimab
Administered as specified in the treatment arm
DRUGDocetaxel
Administered as specified in the treatment arm
DRUGPlatinum-Based Doublet
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically documented Stage IV metastatic, NSCLC * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 * At least one measurable target lesion per RECIST v1.1. * Adequate organ function * Participants must be willing to provide adequate tumor tissue
Exclusion criteria
* Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous * Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s). * Use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (absorbable topical corticosteroids are not excluded). * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * 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 NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to 58 months |
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Up to 58 months |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR) | Up to 58 months |
| Duration of response (DoR) as determined by the Investigator according to RECIST v1.1 | Up to 58 months |
| Investigational study treatments peak plasma or serum concentration (Cmax) | Up to 58 months |
| Overall Survival (OS) | From date of first dose until the date of death due to any cause (approximately 58 months) |
| Investigational study treatments area under the plasma or serum concentration versus time curve (AUC) | Up to 58 months |
| Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants | Up to 58 months |
| Investigational study treatments time of peak concentration (Tmax) | Up to 58 months |
| Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1 | Up to 58 months |
Countries
Australia, France, Georgia, Italy, Poland, South Korea, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed