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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.