TerminatedPhase 1 / Phase 2NCT06173505

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

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).

Checked against the public recordLast updated Mar 13, 2026 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1 / Phase 2
U.S. locations17
SponsorXencor, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Xencor, Inc.
Interventions being studied
Combination Product: Vudalimab + Carboplatin + Pemetrexed; Combination Product: Pembrolizumab + Carboplatin + Pemetrexed
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable * 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 * 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 an acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, or not on established antiretroviral therapy (ART) for at least 4 weeks prior to initiation of study drug dosing. (HIV positive subjects who do not meet these exclusion criteria are eligible) * 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 Other protocol defined inclusion/exclusion criteria apply.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Palo Verde Cancer SpecialistsGlendale, Arizona
  • Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut
  • Hematology Associates of FredericksburgFredericksburg, Virginia
  • Jessa Ziekenhuis - Campus Virga JesseHasselt
  • St. Lukes (Agios Loucas) HospitalThessaloniki
  • Hospital Sultan IsmailJohor Bahru
  • Hospital Umum SarawakKuching
  • Institut Kanser NegaraPutrajaya
  • The Netherlands Cancer Institute - Antoni van LeeuwenhoekAmsterdam, North Holland
  • ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira GuimarãesGuimarães
  • NEXT Oncology-Hospital Quirónsalud BarcelonaBarcelona
  • Hospital Clinic i Provincial de BarcelonaBarcelona

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 13, 2026. Always confirm current availability with the study team.

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