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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 13, 2026 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.