UAB - Center for Clinical and Translational Science

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

Purpose

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

Advanced Non-Small Cell Lung Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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.

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental A1: Domvanalimab + Zimberelimab	Domvanalimab and Zimberelimab, both administered by IV infusion	Drug: Domvanalimab Administered as specified in the treatment arm Drug: Zimberelimab Administered as specified in the treatment arm
Experimental A2: Domvanalimab + Zimberelimab	Domvanalimab and Zimberelimab, both administered by IV infusion	Drug: Domvanalimab Administered as specified in the treatment arm Drug: Zimberelimab Administered as specified in the treatment arm
Experimental A3: Quemliclustat + Zimberelimab	Quemliclustat and Zimberelimab, both administered by IV infusion	Drug: Quemliclustat Administered as specified in the treatment arm Drug: Zimberelimab Administered as specified in the treatment arm
Experimental B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy	Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion	Drug: Quemliclustat Administered as specified in the treatment arm Drug: Zimberelimab 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: Domvanalimab Administered as specified in the treatment arm Drug: Zimberelimab 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: Domvanalimab Administered as specified in the treatment arm Drug: Quemliclustat Administered as specified in the treatment arm Drug: Zimberelimab 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: Quemliclustat Administered as specified in the treatment arm Drug: Zimberelimab 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: Domvanalimab 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

Recruiting Locations

University of Alabama at Birmingham (UAB)
Birmingham, Alabama 35294

More Details

Status: Recruiting
Sponsor: Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com