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Experimental lung cancer drug trial halted early

NCT ID NCT06173505

Disease control Sponsor: Xencor, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a new immunotherapy drug called vudalimab combined with chemotherapy as a first treatment for advanced non-small cell lung cancer. It compared this combination to the standard treatment of pembrolizumab plus chemotherapy. The study was terminated early after enrolling only 28 people, so it is unclear if vudalimab offers any benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vudalimab (an experimental immunotherapy drug) combined with chemotherapy (carboplatin and pemetrexed)
What this could lead to
If successful, this could point toward a new first-line treatment option for advanced non-small cell lung cancer.
What could go wrong
This trial was terminated early with only 28 participants, so results are very limited. It is too early to know if vudalimab is safe or effective compared to existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

28 people

The number who actually took part.

Started

Dec 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nonsquamous non small cell lung cancer

Contacts and locations

Locations

  • Changhua Christian Hospital

    Changhua, 500, Taiwan

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticut, 06360, United States

  • Hematology Associates of Fredericksburg

    Fredericksburg, Virginia, 22408, United States

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Sultan Ismail

    Johor Bahru, 81100, Malaysia

  • Hospital Umum Sarawak

    Kuching, 93586, Malaysia

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Institut Català d'Oncolgia de Girona

    Girona, 17007, Spain

  • Institut Kanser Negara

    Putrajaya, 62250, Malaysia

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500, Belgium

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • NEXT Oncology-Hospital Quirónsalud Barcelona

    Barcelona, 08023, Spain

  • Palo Verde Cancer Specialists

    Glendale, Arizona, 85304, United States

  • St. Lukes (Agios Loucas) Hospital

    Thessaloniki, 552 36, Greece

  • The Netherlands Cancer Institute - Antoni van Leeuwenhoek

    Amsterdam, North Holland, 1066 CX, Netherlands

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

    Guimarães, 4835-044, Portugal

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