Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2026-01-07 @ 5:45 PM
Study NCT ID:
NCT06847334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-26
First Post:
2025-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 772}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-01-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the serum concentration-time curve from time 0 to 21 days (AUC0-21d)', 'timeFrame': 'Up to Day 21'}, {'measure': 'Area under the serum concentration-time curve within a dosing interval at steady state (AUCss)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Best Objective Response Rate (BORR) assessed by Independent Radiology Review Committee (IRRC) based on RECIST v1.1', 'timeFrame': 'up to week 24'}], 'secondaryOutcomes': [{'measure': 'Maximum serum drug concentration (Cmax) after the first dose', 'timeFrame': 'Up to Day 21'}, {'measure': 'Trough serum drug concentration (Ctrough) after the first dose', 'timeFrame': 'Up to Day 21'}, {'measure': 'Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) after the first dose', 'timeFrame': 'Up to Day 21'}, {'measure': 'Area under the serum concentration-time curve extrapolated from time t to infinity as a percentage of total AUC (%AUCex) after the first dose', 'timeFrame': 'Up to Day 21'}, {'measure': 'Time to reach maximum serum drug concentration (Tmax) after the first dose', 'timeFrame': 'Up to Day 21'}, {'measure': 'Elimination half life (t1/2) after the first dose', 'timeFrame': 'Up to Day 21'}, {'measure': 'Volume of distribution during terminal phase (Vz) after the first dose', 'timeFrame': 'Up to Day 21'}, {'measure': 'Total clearance (CL) after the first dose', 'timeFrame': 'Up to Day 21'}, {'measure': 'Mean residence time (MRT) after the first dose', 'timeFrame': 'Up to Day 21'}, {'measure': 'Maximum serum drug concentration at steady-state (Cmax, ss)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Trough serum drug concentration at steady-state (Ctrough, ss)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Average serum drug concentration at steady-state (Cave, ss)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Time to reach maximum serum drug concentration at steady-state (Tmax, ss)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Elimination half life at steady-state (t1/2, ss)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Volume of distribution at steady-state (Vss)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Total clearance at steady-state (CLss)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Accumulation ratio of AUC (Rac(AUC))', 'timeFrame': 'Up to 1 year'}, {'measure': 'Accumulation ratio of Cmax (Rac(Cmax))', 'timeFrame': 'Up to 1 year'}, {'measure': 'Objective response rate (ORR) assessed by IRRC (based on RECIST v1.1)', 'timeFrame': 'Up to Week 24'}, {'measure': 'Objective response rate (ORR) assessed by Investigator (based on RECIST v1.1)', 'timeFrame': 'Up to Week 48'}, {'measure': 'Duration of response (DOR) assessed by the investigator (based on RECIST v1.1)', 'timeFrame': 'Up to Week 48'}, {'measure': 'Time to response (TTR) assessed by the investigator (based on RECIST v1.1)', 'timeFrame': 'Up to Week 48'}, {'measure': 'Progression free survival (PFS) assessed by the investigator (based on RECIST v1.1)', 'timeFrame': 'Up to Week 48'}, {'measure': 'Progression free survival rate (PFSR) assessed by the investigator (based on RECIST v1.1)', 'timeFrame': 'Up to Week 48'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Overall survival rate (OSR)', 'timeFrame': 'Up to 1 year'}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'Up to Month 15'}, {'measure': 'Serious adverse events (SAEs)', 'timeFrame': 'Up to Month 15'}, {'measure': 'Incidence of anti-drug antibodies (ADAs).', 'timeFrame': 'Up to 1 year'}, {'measure': 'Incidence of neutralizing antibodies (NAbs).', 'timeFrame': 'Up to 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keytruda biosimilar'], 'conditions': ['Non-Squamous Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I/III clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs. Keytruda®( US- and EU-sourced) in the first-line treatment of advanced non-squamous non-small cell lung cancer.', 'detailedDescription': 'This study includes three treatment groups. Patients will be randomly assigned at a 2:1:1 ratio to the HLX17, US-sourced Keytruda® and EU-sourced Keytruda® group to receive the treatment of IMPs in combination with Carboplatin Plus Pemetrexed until disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent form, death, unacceptable toxicity, or up to 17 cycles (whichever occurs first).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC.\n* Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.\n* Have not received prior systemic treatment for their advanced/metastatic NSCLC.\n* At least one measurable lesion as assessed by IRRC based on RECIST v1.1.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n* Have adequate organ function.\n\nExclusion Criteria:\n\n* Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.\n* Subjects with other active malignancies within 5 years or at the same time prior to screening.\n* Active central nervous system metastases.\n* Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity.\n* Known active or suspected autoimmune diseases.\n* History of immunodeficiency, including HIV antibody positive, active hepatitis B; or hepatitis C virus infections.\n* Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before screening.\n* Pregnant or breastfeeding female.\n* The investigator has a clear reason to believe that participation in this study would be detrimental to the subject."}, 'identificationModule': {'nctId': 'NCT06847334', 'briefTitle': 'A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Henlius Biotech'}, 'officialTitle': 'A Multicentre, Randomized, Double-Blind, Parallel-Controlled Integrated Phase I/III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Profile of HLX17 Vs. Keytruda® (US-sourced Keytruda® and EU-sourced Keytruda®) in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'HLX17-NSCLC301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HLX17 group', 'description': 'Recombinant anti-programmed death receptor-1- humanized antibody injection developed by Shanghai Henlius Biotech, Inc.', 'interventionNames': ['Drug: HLX17']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'US-sourced Keytruda® group', 'description': 'US-sourced Keytruda', 'interventionNames': ['Drug: US-sourced Keytruda®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EU-sourced Keytruda® group', 'description': 'EU-sourced Keytruda', 'interventionNames': ['Drug: EU-sourced Keytruda®']}], 'interventions': [{'name': 'HLX17', 'type': 'DRUG', 'description': 'HLX17 will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.', 'armGroupLabels': ['HLX17 group']}, {'name': 'US-sourced Keytruda®', 'type': 'DRUG', 'description': 'US-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed. After 24 weeks, all subjects in the US-Keytruda® group will receive HLX17 in combination with Pemetrexed until loss of clinical benefit or up to 1 year.', 'armGroupLabels': ['US-sourced Keytruda® group']}, {'name': 'EU-sourced Keytruda®', 'type': 'DRUG', 'description': 'EU-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.', 'armGroupLabels': ['EU-sourced Keytruda® group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Henlius Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}