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

NCT06173505 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: XmAb717-06
• Study Type: interventional
• Target: 28
• Locations: 8 countries
• Sites: 17

Brief Summary

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).

Conditions

Nonsquamous Non-small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy

  Incidence of treatment-emergent adverse events and treatment-related adverse events leading to discontinuation of treatment

  Day 1 to Day 21

• Part 2: Progression free survival

  Progressive disease per RECIST 1.1 or death, whichever comes first

  Day 1 to 2.5 years

Secondary Outcomes (7)

• Antitumor activity

  Day 1 to 1.4 years

• Changes in circulating tumor DNA (ctDNA)

  Day 1 to 1.4 years

• Maximum Serum Drug Concentration (Cmax)

  Day 1 to 1.4 years

• Trough Serum Drug Concentration (Ctrough)

  Day 1 to 1.4 years

• Area Under the Concentration-time Curve (AUC)

  Day 1 to 1.4 years

Study Arms (2)

Vudalimab + Carboplatin + Pemetrexed

EXPERIMENTAL

Combination Product: Vudalimab + Carboplatin + Pemetrexed

Pembrolizumab + Carboplatin + Pemetrexed

ACTIVE COMPARATOR

Combination Product: Pembrolizumab + Carboplatin + Pemetrexed

Interventions

Vudalimab + Carboplatin + Pemetrexed COMBINATION_PRODUCT

Vudalimab intravenous + carboplatin intravenous + pemetrexed intravenous

Vudalimab + Carboplatin + Pemetrexed

Pembrolizumab + Carboplatin + Pemetrexed COMBINATION_PRODUCT

Pembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous

Pembrolizumab + Carboplatin + Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (17)

Palo Verde Cancer Specialists

Glendale, Arizona, 85304, United States

Location

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Hematology Associates of Fredericksburg

Fredericksburg, Virginia, 22408, United States

Location

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, 3500, Belgium

Location

St. Lukes (Agios Loucas) Hospital

Thessaloniki, 552 36, Greece

Location

Hospital Sultan Ismail

Johor Bahru, 81100, Malaysia

Location

Hospital Umum Sarawak

Kuching, 93586, Malaysia

Location

Institut Kanser Negara

Putrajaya, 62250, Malaysia

Location

The Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, North Holland, 1066 CX, Netherlands

Location

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

Guimarães, 4835-044, Portugal

Location

NEXT Oncology-Hospital Quirónsalud Barcelona

Barcelona, 08023, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Institut Català d'Oncolgia de Girona

Girona, 17007, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Changhua Christian Hospital

Changhua, 500, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Pemetrexed; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Jolene Shorr

  Executive Director, Clinical Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: December 15, 2023
• Study Start: December 27, 2023
• Primary Completion: December 24, 2025
• Study Completion: December 29, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (3); PT (1); NL (1); MY (3); ES (5); TW (2); BE (1); GR (1)