Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC
NCT ID: NCT06173505
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
168 participants
INTERVENTIONAL
2023-12-27
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vudalimab + Carboplatin + Pemetrexed
Vudalimab + Carboplatin + Pemetrexed
Vudalimab intravenous + carboplatin intravenous + pemetrexed intravenous
Pembrolizumab + Carboplatin + Pemetrexed
Pembrolizumab + Carboplatin + Pemetrexed
Pembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous
Interventions
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Vudalimab + Carboplatin + Pemetrexed
Vudalimab intravenous + carboplatin intravenous + pemetrexed intravenous
Pembrolizumab + Carboplatin + Pemetrexed
Pembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Active known or suspected autoimmune disease
* Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
* Interstitial lung disease that is symptomatic
* Positive test for hepatitis C RNA (a patient who is hepatitis C virus \[HCV\] antibody positive but HCV RNA negative due to documented, curative prior antiviral treatment or 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 a hepatitis B virus (HBV) DNA test is negative and the subject is retested for HbsAg and HBV DNA every 2 months)
* History or evidence of any clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than NSCLC, that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study evaluations, procedures, or completion
18 Years
ALL
No
Sponsors
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Xencor, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jolene Shorr
Role: STUDY_DIRECTOR
Executive Director, Clinical Development
Locations
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Palo Verde Cancer Specialists
Glendale, Arizona, United States
Western Regional Medical Center
Goodyear, Arizona, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Memorial Cancer Institute at Memorial Hospital West
Pembroke Pines, Florida, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Minnesota Oncology Hematology, P.A.
Maple Grove, Minnesota, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
New Jersey Center for Cancer Research
Brick, New Jersey, United States
Cancer Institute at Phelps
Sleepy Hollow, New York, United States
Consultants in Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, United States
Alliance Cancer Specialists
Horsham, Pennsylvania, United States
Hematology Associates of Fredericksburg
Fredericksburg, Virginia, United States
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, , Belgium
Athens Medical Center
Athens, , Greece
St. Lukes (Agios Loucas) Hospital
Thessaloniki, , Greece
Hospital Canselor Tuanku Muhriz
Cheras, , Malaysia
Pantai Hospital Ipoh
Ipoh, , Malaysia
Hospital Sultan Ismail
Johor Bahru, , Malaysia
Hospital Umum Sarawak
Kuching, , Malaysia
Institut Kanser Negara
Putrajaya, , Malaysia
Columbia Asia Hospital Bukit Rimau
Shah Alam, , Malaysia
The Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands
Med-Polonia Sp. Z o.o.
Poznan, , Poland
ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães
Guimarães, , Portugal
Hospital Santo António dos Capuchos - Unidade Local de Saúde de São José
Lisbon, , Portugal
Instituto Português de Oncologia de Porto Francisco Gentil, E.P.E.
Porto, , Portugal
NEXT Oncology-Hospital Quirónsalud Barcelona
Barcelona, , Spain
Hospital Universitario Vall d'Hebrón
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Institut Català d'Oncolgia de Girona
Girona, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
START MADRID-Hospital Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
NEXT Oncology-Hospital Quirónsalud Madrid
Madrid, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Y Politécnico La Fe
Valencia, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
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Central Contacts
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Other Identifiers
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XmAb717-06
Identifier Type: -
Identifier Source: org_study_id