Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06173505
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2023-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 168}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2023-11-13', 'studyFirstSubmitQcDate': '2023-12-07', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Recommended Phase 2 dose of vudalimab in combination with chemotherapy', 'timeFrame': 'Day 1 to Day 21', 'description': 'Incidence of treatment-emergent adverse events and treatment-related adverse events leading to discontinuation of treatment'}, {'measure': 'Part 2: Progression free survival', 'timeFrame': 'Day 1 to 2.5 years', 'description': 'Progressive disease per RECIST 1.1 or death, whichever comes first'}], 'secondaryOutcomes': [{'measure': 'Antitumor activity', 'timeFrame': 'Day 1 to 1.4 years', 'description': 'Objective response rate as determined by investigator, duration of response (Part 1 and Part 2)'}, {'measure': 'Changes in circulating tumor DNA (ctDNA)', 'timeFrame': 'Day 1 to 1.4 years', 'description': 'Examine ctDNA changes as a surrogate marker for disease burden (Part 1 and Part 2)'}, {'measure': 'Maximum Serum Drug Concentration (Cmax)', 'timeFrame': 'Day 1 to 1.4 years', 'description': '(Part 1 and Part 2)'}, {'measure': 'Trough Serum Drug Concentration (Ctrough)', 'timeFrame': 'Day 1 to 1.4 years', 'description': '(Part 1 and Part 2)'}, {'measure': 'Area Under the Concentration-time Curve (AUC)', 'timeFrame': 'Day 1 to 1.4 years', 'description': '(Part 1 and Part 2)'}, {'measure': 'Overall survival', 'timeFrame': 'Day 1 to 2.5 years', 'description': 'Time to death from any cause (Part 2)'}, {'measure': 'Incidence of treatment-emergent adverse events', 'timeFrame': 'Time Frame: Day 1 to 1.4 years]'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer', 'Nonsquamous', 'XmAb20717', 'vudalimab', 'anti-PD-1 x anti-CTLA-4', 'checkpoint inhibitor', 'chemotherapy'], 'conditions': ['Nonsquamous Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': 'This is a Phase 1b/2 study, multicenter, open-label, randomized study in patients with nonsquamous non-small cell lung cancer without prior treatment for metastatic disease. Part 1 is designed to identify the recommended Phase 2 dose (RP2D) of vudalimab, an anti-PD-1/CTLA-4 bispecific antibody, in combination with standard of care (SOC) chemotherapy. Part 2 will evaluate the efficacy and safety vudalimab, at the RP2D, plus SOC relative to pembrolizumab (anti-PD-1) plus SOC chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histologically confirmed, locally advanced (unresectable) or metastatic nonsquamous NSCLC\n* 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\n* PD-L1 IHC testing documenting TPS \\< 49%\n* No prior systemic treatment for advanced/metastatic NSCLC.\n* Measurable disease by RECIST 1.1\n* ECOG performance status score of 0 or 1\n* Life expectancy ≥ 3 months\n* Adequate liver, kidney, thyroid and bone marrow function\n\nKey Exclusion Criteria:\n\n* Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable\n* Active known or suspected autoimmune disease\n* Has any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug\n* Interstitial lung disease that is symptomatic\n* 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)\n* 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)\n* 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)\n* 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\n\nOther protocol defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06173505', 'briefTitle': 'Study of Vudalimab or Pembrolizumab in Combination With Chemotherapy as First-line Treatment in Patients With Advanced NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xencor, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'XmAb717-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vudalimab + Carboplatin + Pemetrexed', 'interventionNames': ['Combination Product: Vudalimab + Carboplatin + Pemetrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pembrolizumab + Carboplatin + Pemetrexed', 'interventionNames': ['Combination Product: Pembrolizumab + Carboplatin + Pemetrexed']}], 'interventions': [{'name': 'Vudalimab + Carboplatin + Pemetrexed', 'type': 'COMBINATION_PRODUCT', 'description': 'Vudalimab intravenous + carboplatin intravenous + pemetrexed intravenous', 'armGroupLabels': ['Vudalimab + Carboplatin + Pemetrexed']}, {'name': 'Pembrolizumab + Carboplatin + Pemetrexed', 'type': 'COMBINATION_PRODUCT', 'description': 'Pembrolizumab intravenous + carboplatin intravenous + pemetrexed intravenous', 'armGroupLabels': ['Pembrolizumab + Carboplatin + Pemetrexed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Palo Verde Cancer Specialists', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85338', 'city': 'Goodyear', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Western Regional Medical Center', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cancer and Blood Specialty Clinic', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Eastern Connecticut Hematology and Oncology Associates', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mid Florida Hematology and Oncology Center', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '33038', 'city': 'Pembroke Pines', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Cancer Institute at Memorial Hospital West', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '600099', 'city': 'Zion', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Midwestern Regional Medical Center', 'geoPoint': {'lat': 42.44613, 'lon': -87.83285}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55369', 'city': 'Maple Grove', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Minnesota Oncology Hematology, P.A.', 'geoPoint': {'lat': 45.07246, 'lon': -93.45579}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Nebraska Methodist Hospital', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08724', 'city': 'Brick', 'state': 'New Jersey', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'New Jersey Center for Cancer Research', 'geoPoint': {'lat': 40.05928, 'lon': -74.13708}}, {'zip': '10591', 'city': 'Sleepy Hollow', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cancer Institute at Phelps', 'geoPoint': {'lat': 41.08565, 'lon': -73.85847}}, {'zip': '19044', 'city': 'Broomall', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Consultants in Medical Oncology and Hematology, P.C.', 'geoPoint': {'lat': 39.9815, 'lon': -75.35658}}, {'zip': '19044', 'city': 'Horsham', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Alliance Cancer Specialists', 'geoPoint': {'lat': 40.17844, 'lon': -75.12851}}, {'zip': '22408', 'city': 'Fredericksburg', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Hematology Associates of Fredericksburg', 'geoPoint': {'lat': 38.30318, 'lon': -77.46054}}, {'zip': '3500', 'city': 'Hasselt', 'status': 'RECRUITING', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis - Campus Virga Jesse', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '15125', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'facility': 'Athens 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'Malaysia', 'facility': 'Institut Kanser Negara', 'geoPoint': {'lat': 2.93527, 'lon': 101.69112}}, {'zip': '40460', 'city': 'Shah Alam', 'status': 'RECRUITING', 'country': 'Malaysia', 'facility': 'Columbia Asia Hospital Bukit Rimau', 'geoPoint': {'lat': 3.08507, 'lon': 101.53281}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'The Netherlands Cancer Institute - Antoni van Leeuwenhoek', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '60-693', 'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'facility': 'Med-Polonia Sp. 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