Study 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.
Eligible Conditions
- Non Small Cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: Up to 58 months
Month 58
Overall Survival (OS)
Up to 58 months
Disease Control Rate (DCR)
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)
Investigational study treatments peak plasma or serum concentration (Cmax)
Investigational study treatments time of peak concentration (Tmax)
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
8 Treatment Groups
A3: Quemliclustat + Zimberelimab
1 of 8
A1: Domvanalimab + Zimberelimab
1 of 8
C1: Quemliclustat + Zimberelimab + Docetaxel
1 of 8
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
1 of 8
C2: Domvanalimab + Zimberelimab + Docetaxel
1 of 8
A2: Domvanalimab + Zimberelimab
1 of 8
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
1 of 8
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
1 of 8
Experimental Treatment
320 Total Participants · 8 Treatment Groups
Primary Treatment: A3: Quemliclustat + Zimberelimab · No Placebo Group · Phase 2
A3: Quemliclustat + ZimberelimabExperimental Group · 2 Interventions: Zimberelimab, Quemliclustat · Intervention Types: Drug, Drug
A1: Domvanalimab + ZimberelimabExperimental Group · 2 Interventions: Domvanalimab, Zimberelimab · Intervention Types: Drug, Drug
C1: Quemliclustat + Zimberelimab + DocetaxelExperimental Group · 3 Interventions: Zimberelimab, Quemliclustat, Docetaxel · Intervention Types: Drug, Drug, Drug
B2: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyExperimental Group · 3 Interventions: Platinum-Based Doublet, Domvanalimab, Zimberelimab · Intervention Types: Drug, Drug, Drug
C2: Domvanalimab + Zimberelimab + DocetaxelExperimental Group · 3 Interventions: Domvanalimab, Zimberelimab, Docetaxel · Intervention Types: Drug, Drug, Drug
A2: Domvanalimab + ZimberelimabExperimental Group · 2 Interventions: Domvanalimab, Zimberelimab · Intervention Types: Drug, Drug
B1: Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyExperimental Group · 3 Interventions: Platinum-Based Doublet, Zimberelimab, Quemliclustat · Intervention Types: Drug, Drug, Drug
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyExperimental Group · 4 Interventions: Platinum-Based Doublet, Domvanalimab, Zimberelimab, Quemliclustat · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimberelimab
2018
Completed Phase 1
~50
Docetaxel
1995
Completed Phase 4
~8840
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 58 months
Who is running the clinical trial?
Arcus Biosciences, Inc.Lead Sponsor
31 Previous Clinical Trials
5,362 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,017 Previous Clinical Trials
656,079 Total Patients Enrolled
Medical DirectorStudy DirectorArcus Biosciences
2,638 Previous Clinical Trials
7,941,677 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a medically verified diagnosis of Stage IV metastatic non-small cell lung cancer.
You have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
You have a minimum of one visible target lesion that meets the criteria defined by Response Evaluation Criteria In Solid Tumors v1.1.
Your organs and bones are functioning properly.
Participants must be prepared to supply sufficient tumor tissue.
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Conditions
Cancer Related
Treatments