EDGE-Lung: Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer

Sponsor

Arcus Biosciences, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05676931

Collaborator

Gilead Sciences (Industry)

320

Enrollment

Location

Arms

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Non-Small Cell Lung Cancer	Drug: Zimberelimab Drug: Domvanalimab Drug: Quemliclustat Drug: Platinum-Based Doublet Drug: Docetaxel	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A1: Domvanalimab + Zimberelimab Domvanalimab and Zimberelimab, both administered by IV infusion	Drug: Zimberelimab Administered as specified in the treatment arm Drug: Domvanalimab Administered as specified in the treatment arm
Experimental: A2: Domvanalimab + Zimberelimab Domvanalimab and Zimberelimab, both administered by IV infusion	Drug: Zimberelimab Administered as specified in the treatment arm Drug: Domvanalimab Administered as specified in the treatment arm
Experimental: A3: Quemliclustat + Zimberelimab Quemliclustat and Zimberelimab, both administered by IV infusion	Drug: Zimberelimab Administered as specified in the treatment arm Drug: Quemliclustat Administered as specified in the treatment arm
Experimental: B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy Domvanalimab, Quemliclustat, and platinum doublet chemotherapy, all administered by IV infusion	Drug: Zimberelimab Administered as specified in the treatment arm Drug: Quemliclustat Administered as specified in the treatment arm Drug: Platinum-Based Doublet Administered as specified in the treatment arm
Experimental: B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion	Drug: Zimberelimab Administered as specified in the treatment arm Drug: Domvanalimab Administered as specified in the treatment arm Drug: Platinum-Based Doublet Administered as specified in the treatment arm
Experimental: B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion	Drug: Zimberelimab Administered as specified in the treatment arm Drug: Domvanalimab Administered as specified in the treatment arm Drug: Quemliclustat Administered as specified in the treatment arm Drug: Platinum-Based Doublet Administered as specified in the treatment arm
Experimental: C1: Quemliclustat + Zimberelimab + Docetaxel Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion	Drug: Zimberelimab Administered as specified in the treatment arm Drug: Quemliclustat Administered as specified in the treatment arm Drug: Docetaxel Administered as specified in the treatment arm
Experimental: C2: Domvanalimab + Zimberelimab + Docetaxel Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion	Drug: Zimberelimab Administered as specified in the treatment arm Drug: Domvanalimab Administered as specified in the treatment arm Drug: Docetaxel Administered as specified in the treatment arm

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Overall Survival (OS) [From date of first dose until the date of death due to any cause (approximately 58 months)]
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1 [Up to 58 months]
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]
Investigational study treatments time of peak concentration (Tmax) [Up to 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed, documented diagnosis of 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 and marrow 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).
Concurrent chronic medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (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/Exclusion criteria may apply.