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

Description

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.

Conditions

Advanced Non-Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Non-Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

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

La Jolla

University of California San Diego (UCSD), La Jolla, California, United States, 92093

Hollywood

Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, United States, 33021

Port Saint Lucie

Hematology Oncology Associates Of The Treasure Coast, Port Saint Lucie, Florida, United States, 34952

Sarasota

Florida Cancer Specialists (Administration and Drug Shipment), Sarasota, Florida, United States, 34232

Tallahassee

Florida Cancer Specialists, Tallahassee, Florida, United States, 32308

The Villages

Florida Cancer Specialists (Administration and Drug Shipment), The Villages, Florida, United States, 32163

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Jefferson

Ochsner Clinic Foundation, Jefferson, Louisiana, United States, 70121

Detroit

Henry Ford Hospital, Detroit, Michigan, United States, 48202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2027-12