RECRUITING

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

Conditions

Nonsquamous Non-small Cell Lung Cancer Non-small cell lung cancer Nonsquamous XmAb20717 vudalimab anti-PD-1 x anti-CTLA-4 checkpoint inhibitor chemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-12-27

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06173505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Michael Chiarella

CONTACT

1-858-945-2415

mchiarella@xencor.com

Principal Investigator

Jolene Shorr

STUDY_DIRECTOR

Executive Director, Clinical Development

Study Locations (Sites)

Palo Verde Cancer Specialists

Glendale, Arizona, 85304

United States

Western Regional Medical Center

Goodyear, Arizona, 85338

United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720

United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360

United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763

United States

Memorial Cancer Institute at Memorial Hospital West

Pembroke Pines, Florida, 33038

United States

Midwestern Regional Medical Center

Zion, Illinois, 600099

United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21224

United States

Minnesota Oncology Hematology, P.A.

Maple Grove, Minnesota, 55369

United States

Nebraska Methodist Hospital

Omaha, Nebraska, 68114

United States

New Jersey Center for Cancer Research

Brick, New Jersey, 08724

United States

Cancer Institute at Phelps

Sleepy Hollow, New York, 10591

United States

Consultants in Medical Oncology and Hematology, P.C.

Broomall, Pennsylvania, 19044

United States

Alliance Cancer Specialists

Horsham, Pennsylvania, 19044

United States

Hematology Associates of Fredericksburg

Fredericksburg, Virginia, 22408

United States

Collaborators and Investigators

Sponsor: Xencor, Inc.

Jolene Shorr, STUDY_DIRECTOR, Executive Director, Clinical Development

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-27

Study Completion Date2027-10

Study Record Updates

Study Start Date2023-12-27

Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

Non-small cell lung cancer
Nonsquamous
XmAb20717
vudalimab
anti-PD-1 x anti-CTLA-4
checkpoint inhibitor
chemotherapy

Additional Relevant MeSH Terms

Nonsquamous Non-small Cell Lung Cancer