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Clinical Trials List

Protocol NumberXmAb717-06
NCT Number(ClinicalTrials.gov Identfier)NCT06173505

2024-07-01 - 2027-08-31

Phase I/II

Not yet recruiting2

Recruiting3

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/11/06

Investigators and Locations

Principal Investigator Jen-Yu Hung 無
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator JIN-YUAN SHIH 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 無
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Nonsquamous Non-small Cell Lung Cancer

Objectives

The objectives of this trial are as follows: • To find a safe, tolerable, and recommended dose of vudalimab in combination with chemotherapy for patients with locally advanced (unresectable) or metastatic NSCLC. • To understand how the body absorbs different doses of vudalimab, how it is delivered to different sites of the body, and how the drug is eliminated. • To understand the effect of vudalimab in combination with chemotherapy on tumor reduction. • To understand the effects of vudalimab in combination with chemotherapy on the participants' bodies compared to pembrolizumab. • To test the safety and tolerability of vudalimab in combination with chemotherapy compared to pembrolizumab in combination with chemotherapy. • To understand the effects of vudalimab in combination with chemotherapy on your body, including immune cells, proteins, and tumor cells. • To understand whether vudalimab in combination with chemotherapy is more effective in treating NSCLC and preventing NSCLC progression compared to pembrolizumab in combination with chemotherapy. Xencor hopes to understand the effects (good or bad) of vudalimab on the participants in this trial.

Test Drug

Vudalimab

Active Ingredient

Vudalimab

Dosage Form

246

Dosage

100mg/ 10mL

Endpoints

Part 1: Incidence of TEAEs
Treatment-related adverse events leading to treatment discontinuation
Part 2: PFS (Time elapsed from randomization to disease progression or death according to RECIST 1.1, whichever occurs first)

Inclution 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

Exclusion Criteria

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

The Estimated Number of Participants

  • Taiwan

    16 participants

  • Global

    168 participants

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