A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The purpose of this study is to identify the recommended dose of vudalimab to be used in combination with chemotherapy (Part 1) and to evaluate the efficacy and safety of vudalimab plus standard of care chemotherapy relative to pembrolizumab plus chemotherapy (Part 2) as first-line treatment in patients with nonsquamous non-small cell lung cancer (NSCLC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically confirmed, locally advanced (unresectable) or metastatic nonsquamous NSCLC
• Documented absence of tumor activating EGFR mutation, ALK gene and ROS1 rearrangements, and alterations in any actionable driver oncogenes for which there are locally approved targeted first-line therapies
• PD-L1 IHC testing documenting TPS \< 49%
• No prior systemic treatment for advanced/metastatic NSCLC.
• Measurable disease by RECIST 1.1
• ECOG performance status score of 0 or 1
• Life expectancy ≥ 3 months
• Adequate liver, kidney, thyroid and bone marrow function
Locations
United States
Arizona
Palo Verde Cancer Specialists
RECRUITING
Glendale
Western Regional Medical Center
RECRUITING
Goodyear
California
Cancer and Blood Specialty Clinic
RECRUITING
Los Alamitos
Connecticut
Eastern Connecticut Hematology and Oncology Associates
RECRUITING
Norwich
Florida
Mid Florida Hematology and Oncology Center
RECRUITING
Orange City
Memorial Cancer Institute at Memorial Hospital West
RECRUITING
Pembroke Pines
Illinois
Midwestern Regional Medical Center
RECRUITING
Zion
Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
RECRUITING
Baltimore
Minnesota
Minnesota Oncology Hematology, P.A.
RECRUITING
Maple Grove
Nebraska
Nebraska Methodist Hospital
RECRUITING
Omaha
New Jersey
New Jersey Center for Cancer Research
WITHDRAWN
Brick
New York
Cancer Institute at Phelps
RECRUITING
Sleepy Hollow
Pennsylvania
Consultants in Medical Oncology and Hematology, P.C.
RECRUITING
Broomall
Alliance Cancer Specialists
RECRUITING
Horsham
Virginia
Hematology Associates of Fredericksburg
RECRUITING
Fredericksburg
Other Locations
Belgium
Jessa Ziekenhuis - Campus Virga Jesse
RECRUITING
Hasselt
Greece
Athens Medical Center
RECRUITING
Athens
St. Lukes (Agios Loucas) Hospital
RECRUITING
Thessaloniki
Malaysia
Hospital Canselor Tuanku Muhriz
RECRUITING
Cheras
Pantai Hospital Ipoh
RECRUITING
Ipoh
Hospital Sultan Ismail
RECRUITING
Johor Bahru
Hospital Umum Sarawak
RECRUITING
Kuching
Institut Kanser Negara
RECRUITING
Putrajaya
Columbia Asia Hospital Bukit Rimau
RECRUITING
Shah Alam
Netherlands
The Netherlands Cancer Institute - Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Poland
Med-Polonia Sp. Z o.o.
RECRUITING
Poznan
Portugal
ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães
RECRUITING
Guimarães
Hospital Santo António dos Capuchos - Unidade Local de Saúde de São José
RECRUITING
Lisbon
Instituto Português de Oncologia de Porto Francisco Gentil, E.P.E.
RECRUITING
Porto
Spain
Hospital Clinic i Provincial de Barcelona
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebrón
RECRUITING
Barcelona
NEXT Oncology-Hospital Quirónsalud Barcelona
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Institut Català d'Oncolgia de Girona
RECRUITING
Girona
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
NEXT Oncology-Hospital Quirónsalud Madrid
RECRUITING
Madrid
START MADRID-Hospital Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Universitario Y Politécnico La Fe
RECRUITING
Valencia
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Kaohsiung Medical University Chung-Ho Memorial Hospital
Who is this study for: Patients with stage IV non-small-cell-lung cancer with human immunodeficiency virus infection or hepatitis B virus, or hepatitis C virus infection