ACTIVE_NOT_RECRUITING

Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

Talk to us

Conditions

Non-small Cell Lung Cancer

Quick Navigation

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 primary objective of this study is to compare the effect of zimberelimab (ZIM) and domvanalimab (DOM) in combination with chemotherapy relative to pembrolizumab (PEMBRO) in combination with chemotherapy on overall survival (OS) in patients with untreated metastatic non-small cell lung cancer with no actionable genomic alteration.

Official Title

A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy for the First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

Quick Facts

Study Start:2022-10-12
Study Completion:2029-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05502237

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 CriteriaExclusion Criteria
  1. * Life expectancy ≥ 3 months.
  2. * Pathologically documented NSCLC that meets both of the criteria below:
  3. * Have documented evidence of Stage IV NSCLC disease at the time of enrollment (based on American Joint Committee on Cancer (AJCC), Eighth Edition).
  4. * Have documented negative test results for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) mutations.
  5. * Have no actionable genomic alterations such as ROS proto-oncogene 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations, or other driver oncogenes with approved frontline therapies.
  6. * Have not received prior systemic treatment for metastatic NSCLC.
  7. * Measurable disease per RECIST v1.1 criteria by investigator assessment.
  8. * Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.
  9. * Have adequate organ functions.
  1. * Have mixed small-cell lung cancer (SCLC) and NSCLC histology.
  2. * Positive serum pregnancy test or individuals who are breastfeeding or have plans to breastfeed during the study period.
  3. * Received prior treatment with any anti-PD-1, anti-PD-L1, or any other antibody targeting an immune checkpoint.
  4. * Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
  5. * Have an active second malignancy or have had an active second malignancy within 3 years prior to enrollment.
  6. * Have an active autoimmune disease that required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
  7. * Are receiving chronic systemic steroids.
  8. * Have significant third-space fluid retention.
  9. * Have untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
  10. * Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment.
  11. * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  12. * Has had an allogenic tissue/solid organ transplant.
  13. * Have received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
  14. * Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Innovative Clinical Research Institute
Whittier, California, 90606
United States
George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20052
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Illinois Cancer Care
Peoria, Illinois, 61615
United States
Messino Cancer Centers
Asheville, North Carolina, 28806
United States
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
United States
Hematology & Oncology Associates
Eugene, Oregon, 97401
United States
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
Texas Oncology - Austin
Austin, Texas, 78745
United States
Oncology and Hematology Associates of Southwest Virginia, Inc
Blacksburg, Virginia, 24060
United States
Northwest Cancer Specialists, PC
Vancouver, Washington, 98684
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 Date2022-10-12
Study Completion Date2029-01

Study Record Updates

Study Start Date2022-10-12
Study Completion Date2029-01

Terms related to this study

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer