Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-27 @ 4:07 PM
Study NCT ID:
NCT06939595
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic 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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 606}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-21', 'studyFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2025-04-21', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR based on the confirmed best overall response (BOR) by the end of Cycle 11 according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1', 'timeFrame': 'Up to 34 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Squamous Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P51 and European Union (EU) approved Keytruda in combination with platinum pemetrexed chemotherapy in patients with previously untreated metastatic nsNSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stage IV, non squamous NSCLC\n* Have not received any prior systemic anti-cancer therapy for metastatic NSCLC\n* Have at least 1 measurable lesion per RECIST version 1.1\n\nExclusion Criteria:\n\n* Have predominantly squamous cell histology NSCLC.\n* Hypersensitivity or contraindication to any component of the study drug, pemetrexed and cisplatin or carboplatin'}, 'identificationModule': {'nctId': 'NCT06939595', 'briefTitle': 'A Study to Compare Effects and Safety of CT-P51 and Keytruda in Patients With Previously Untreated Metastatic Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'A Double-Blind, Randomized, Active-Controlled, Parallel-Group, Phase 3 Study to Compare Efficacy and Safety of CT-P51 and Keytruda in Combination With Platinum-Pemetrexed Chemotherapy in Patients With Previously Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CT-P51 3.1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-P51', 'interventionNames': ['Drug: CT-P51']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EU-approved Keytruda', 'interventionNames': ['Drug: EU-approved Keytruda']}], 'interventions': [{'name': 'CT-P51', 'type': 'DRUG', 'description': 'CT-P51 200mg with pemetrexed and cisplatin or carboplatin will be administered every 3 weeks for a maximum of 4 cycles followed by CT-P51 or Keytruda and pemetrexed every 3 weeks', 'armGroupLabels': ['CT-P51']}, {'name': 'EU-approved Keytruda', 'type': 'DRUG', 'description': 'Keytruda 200mg with pemetrexed and cisplatin or carboplatin will be administered every 3 weeks for a maximum of 4 cycles followed by CT-P51 or Keytruda and pemetrexed every 3 weeks', 'armGroupLabels': ['EU-approved Keytruda']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tbilisi', 'status': 'RECRUITING', 'country': 'Georgia', 'contacts': [{'name': 'Vladimer Kuchava', 'role': 'CONTACT', 'email': 'ladokuchava@gmail.com', 'phone': '+995 995322 93306163'}], 'facility': 'ltd "Institute of Clinical Oncology"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}], 'centralContacts': [{'name': 'Jaeyoung Jang', 'role': 'CONTACT', 'email': 'jaeyoung.jang@celltrion.com', 'phone': '+82 32 850 5769'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltrion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}