Overview

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

Status:
Recruiting
Trial end date:
2026-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Arcus Biosciences, Inc.
Collaborator:
Gilead Sciences
Treatments:
Docetaxel
Criteria
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.