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Combining Vudalimab or Pembrolizumab with Chemotherapy for Advanced Lung Cancer

A Phase 1b/2, Open-label, Randomized Study of Vudalimab in Combination With Chemotherapy or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced Non-small Cell Lung Cancer

Phase1; Phase2 Interventional Xencor, Inc. · NCT06173505

This study is testing the best dose of a new drug called vudalimab when used with chemotherapy for people with advanced lung cancer, and comparing it to another treatment called pembrolizumab with chemotherapy.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment168 (estimated)
Ages18 Years and up
SexAll
SponsorXencor, Inc. Industry-sponsored
Drugs / interventionsprednisone, vudalimab, pembrolizumab, chemotherapy
Locations43 sites (Glendale, Arizona and 42 other locations)
Trial IDNCT06173505 on ClinicalTrials.gov

What this trial studies

This study aims to determine the optimal dose of vudalimab, a bispecific antibody targeting PD-1 and CTLA-4, when used alongside standard chemotherapy in patients with advanced nonsquamous non-small cell lung cancer (NSCLC). It consists of two parts: the first part focuses on identifying the recommended Phase 2 dose of vudalimab, while the second part compares the efficacy and safety of vudalimab combined with chemotherapy against pembrolizumab combined with chemotherapy. The study is multicenter, open-label, and randomized, involving patients who have not received prior treatment for metastatic disease.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed, locally advanced or metastatic nonsquamous NSCLC who have not received prior systemic treatment.

Not a fit: Patients with known active central nervous system metastases or those with active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced nonsquamous NSCLC.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Glendale, Arizona and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Nonsquamous Non-small Cell Lung CancerNon-small cell lung cancerNonsquamousXmAb20717vudalimabanti-PD-1 x anti-CTLA-4checkpoint inhibitorchemotherapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.