Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC

Last updated: December 2, 2024
Sponsor: Xencor, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

N/A

Treatment

Pembrolizumab + Carboplatin + Pemetrexed

Vudalimab + Carboplatin + Pemetrexed

Clinical Study ID

NCT06173505
XmAb717-06
  • Ages > 18
  • All Genders

Study 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 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

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: Pembrolizumab + Carboplatin + Pemetrexed
Phase: 1/2
Study Start date:
December 27, 2023
Estimated Completion Date:
October 31, 2027

Study Description

This is a Phase 1b/2 study, multicenter, open-label, randomized study in patients with nonsquamous non-small cell lung cancer without prior treatment for metastatic disease. Part 1 is designed to identify the recommended Phase 2 dose (RP2D) of vudalimab, an anti-PD-1/CTLA-4 bispecific antibody, in combination with standard of care (SOC) chemotherapy. Part 2 will evaluate the efficacy and safety vudalimab, at the RP2D, plus SOC relative to pembrolizumab (anti-PD-1) plus SOC chemotherapy.

Connect with a study center

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • Athens Medical Center

    Athens, 15125
    Greece

    Active - Recruiting

  • St. Lukes (Agios Loucas) Hospital

    Thessaloníki, 552 36
    Greece

    Active - Recruiting

  • Hospital Canselor Tuanku Muhriz

    Cheras, 56000
    Malaysia

    Active - Recruiting

  • Pantai Hospital Ipoh

    Ipoh, 31400
    Malaysia

    Active - Recruiting

  • Hospital Sultan Ismail

    Johor Bahru, 81100
    Malaysia

    Active - Recruiting

  • Hospital Canselor Tuanku Muhriz

    Kuala Lumpur, 56000
    Malaysia

    Site Not Available

  • Hospital Umum Sarawak

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • Institut Kanser Negara

    Putrajaya, 62250
    Malaysia

    Active - Recruiting

  • Columbia Asia Hospital Bukit Rimau

    Shah Alam, 40460
    Malaysia

    Active - Recruiting

  • The Netherlands Cancer Institute - Antoni van Leeuwenhoek

    Amsterdam, North Holland 1066 CX
    Netherlands

    Active - Recruiting

  • Med-Polonia Sp. Z o.o.

    Poznań, 60-693
    Poland

    Active - Recruiting

  • ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães

    Guimarães, 4835-044
    Portugal

    Active - Recruiting

  • Hospital Santo António dos Capuchos - Unidade Local de Saúde de São José

    Lisboa, 1169-050
    Portugal

    Active - Recruiting

  • Instituto Português de Oncologia de Porto Francisco Gentil, E.P.E.

    Porto, 4200-072
    Portugal

    Active - Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebrón

    Barcelona, 08035
    Spain

    Active - Recruiting

  • NEXT Oncology-Hospital Quirónsalud Barcelona

    Barcelona, 08023
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Institut Català d'Oncolgia de Girona

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Active - Recruiting

  • NEXT Oncology-Hospital Quirónsalud Madrid

    Madrid, 28223
    Spain

    Active - Recruiting

  • START MADRID-Hospital Fundacion Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Y Politécnico La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua, 500
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    Tainan City, 704
    Taiwan

    Active - Recruiting

  • Palo Verde Cancer Specialists

    Glendale, Arizona 85304
    United States

    Active - Recruiting

  • Western Regional Medical Center

    Goodyear, Arizona 85338
    United States

    Active - Recruiting

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California 90720
    United States

    Active - Recruiting

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut 06360
    United States

    Active - Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Memorial Cancer Institute at Memorial Hospital West

    Pembroke Pines, Florida 33038
    United States

    Active - Recruiting

  • Midwestern Regional Medical Center

    Zion, Illinois 600099
    United States

    Active - Recruiting

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology, P.A.

    Maple Grove, Minnesota 55369
    United States

    Active - Recruiting

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • New Jersey Center for Cancer Research

    Brick, New Jersey 08724
    United States

    Site Not Available

  • Cancer Institute at Phelps

    Sleepy Hollow, New York 10591
    United States

    Active - Recruiting

  • Consultants in Medical Oncology and Hematology, P.C.

    Broomall, Pennsylvania 19044
    United States

    Active - Recruiting

  • Alliance Cancer Specialists

    Horsham, Pennsylvania 19044
    United States

    Active - Recruiting

  • Hematology Associates of Fredericksburg

    Fredericksburg, Virginia 22408
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.