ACTIVE_NOT_RECRUITING

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Conditions

Advanced Non-Small Cell Lung Cancer Domvanalimab Zimberelimab Quemliclustat Anti-TIGIT antibody Anti-PD-1 antibody

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2023-02-21

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05676931

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically or cytologically documented 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 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). * Use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (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

Inclusion Criteria

Exclusion Criteria

* Histologically or cytologically documented 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 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).
* Use of supra-physiologic doses of corticosteroids (\> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (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

Contacts and Locations

Principal Investigator

Gilead Study Director

STUDY_DIRECTOR

Gilead Sciences

Study Locations (Sites)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294

United States

University of California San Diego (UCSD)

La Jolla, California, 92093

United States

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, 33021

United States

Hematology Oncology Associates Of The Treasure Coast

Port Saint Lucie, Florida, 34952

United States

Florida Cancer Specialists (Administration and Drug Shipment)

The Villages, Florida, 32163

United States

Northwestern Memorial Hospital

Chicago, Illinois, 60611

United States

Ochsner Clinic Foundation

Jefferson, Louisiana, 70121

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

Medical Oncology Associated, PS (dba Summit Cancer Centers)

Spokane, Washington, 99208

United States

Collaborators and Investigators

Sponsor: Gilead Sciences

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-21

Study Completion Date2027-12

Study Record Updates

Study Start Date2023-02-21

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Advanced Non-Small Cell Lung Cancer
Domvanalimab
Zimberelimab
Quemliclustat
Anti-TIGIT antibody
Anti-PD-1 antibody

Additional Relevant MeSH Terms

Advanced Non-Small Cell Lung Cancer