Phase
Condition
N/ATreatment
Pembrolizumab + Carboplatin + Pemetrexed
Vudalimab + Carboplatin + Pemetrexed
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Histologically confirmed, locally advanced (unresectable) or metastatic nonsquamousNSCLC
Documented absence of tumor activating EGFR mutation, ALK gene and ROS1rearrangements, and alterations in any actionable driver oncogenes for which thereare 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
Exclusion
Key Exclusion Criteria:
Have known active central nervous system metastases and/or carcinomatous meningitis.Patients with treated brain metastases may participate, provided they areradiologically stable
Active known or suspected autoimmune disease
Has any condition requiring systemic treatment with corticosteroids, prednisoneequivalents, or other immunosuppressive medications within 14 days prior to firstdose of study drug
Interstitial lung disease that is symptomatic
Known human immunodeficiency virus (HIV) positive with CD4+ T-cell (CD4+) count < 350 cells/μL, or an HIV viral load greater than 400 copies/mL, or a history of anacquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, or not on established antiretroviral therapy (ART) for at least 4 weeksprior to initiation of study drug dosing. (HIV positive subjects who do not meetthese exclusion criteria are eligible)
Positive test for hepatitis C RNA (a patient who is hepatitis C virus [HCV] antibodypositive but HCV RNA negative due to documented, curative prior antiviral treatmentor natural resolution is eligible)
Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb) (a patient whose hBsAg is negative and hBcAb is positive may be enrolled if ahepatitis B virus (HBV) DNA test is negative and the subject is retested for HbsAgand HBV DNA every 2 months)
History or evidence of any clinically unstable/uncontrolled disorder, condition, ordisease (including, but not limited to, cardiopulmonary, renal, metabolic,hematologic, or psychiatric) other than NSCLC, that, in the opinion of theInvestigator, would pose a risk to patient safety or interfere with studyevaluations, procedures, or completion
Other protocol defined inclusion/exclusion criteria apply.
Study Design
Study Description
Connect with a study center
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500
BelgiumActive - Recruiting
Athens Medical Center
Athens, 15125
GreeceActive - Recruiting
St. Lukes (Agios Loucas) Hospital
Thessaloníki, 552 36
GreeceActive - Recruiting
Hospital Canselor Tuanku Muhriz
Cheras, 56000
MalaysiaActive - Recruiting
Pantai Hospital Ipoh
Ipoh, 31400
MalaysiaActive - Recruiting
Hospital Sultan Ismail
Johor Bahru, 81100
MalaysiaActive - Recruiting
Hospital Canselor Tuanku Muhriz
Kuala Lumpur, 56000
MalaysiaSite Not Available
Hospital Umum Sarawak
Kuching, 93586
MalaysiaActive - Recruiting
Institut Kanser Negara
Putrajaya, 62250
MalaysiaActive - Recruiting
Columbia Asia Hospital Bukit Rimau
Shah Alam, 40460
MalaysiaActive - Recruiting
The Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, North Holland 1066 CX
NetherlandsActive - Recruiting
Med-Polonia Sp. Z o.o.
Poznań, 60-693
PolandActive - Recruiting
ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães
Guimarães, 4835-044
PortugalActive - Recruiting
Hospital Santo António dos Capuchos - Unidade Local de Saúde de São José
Lisboa, 1169-050
PortugalActive - Recruiting
Instituto Português de Oncologia de Porto Francisco Gentil, E.P.E.
Porto, 4200-072
PortugalActive - Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitario Vall d'Hebrón
Barcelona, 08035
SpainActive - Recruiting
NEXT Oncology-Hospital Quirónsalud Barcelona
Barcelona, 08023
SpainActive - Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
SpainActive - Recruiting
Institut Català d'Oncolgia de Girona
Girona, 17007
SpainActive - Recruiting
Hospital Clínico San Carlos
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
NEXT Oncology-Hospital Quirónsalud Madrid
Madrid, 28223
SpainActive - Recruiting
START MADRID-Hospital Fundacion Jimenez Diaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario Y Politécnico La Fe
Valencia, 46026
SpainActive - Recruiting
Changhua Christian Hospital
Changhua, 500
TaiwanActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan City, 704
TaiwanActive - Recruiting
Palo Verde Cancer Specialists
Glendale, Arizona 85304
United StatesActive - Recruiting
Western Regional Medical Center
Goodyear, Arizona 85338
United StatesActive - Recruiting
Cancer and Blood Specialty Clinic
Los Alamitos, California 90720
United StatesActive - Recruiting
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut 06360
United StatesActive - Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
United StatesActive - Recruiting
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida 33038
United StatesActive - Recruiting
Midwestern Regional Medical Center
Zion, Illinois 600099
United StatesActive - Recruiting
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21224
United StatesActive - Recruiting
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota 55369
United StatesActive - Recruiting
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United StatesActive - Recruiting
New Jersey Center for Cancer Research
Brick, New Jersey 08724
United StatesSite Not Available
Cancer Institute at Phelps
Sleepy Hollow, New York 10591
United StatesActive - Recruiting
Consultants in Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania 19044
United StatesActive - Recruiting
Alliance Cancer Specialists
Horsham, Pennsylvania 19044
United StatesActive - Recruiting
Hematology Associates of Fredericksburg
Fredericksburg, Virginia 22408
United StatesActive - Recruiting
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