Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT04332367
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2020-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance
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': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}, {'id': 'D000096662', 'term': 'Ramucirumab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-12', 'size': 189090, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-03-10T15:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2020-03-11', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To estimate overall response rate', 'timeFrame': '3 years', 'description': 'Overall response rate (ORR) as determined by RECIST criteria. Response will be defined by a complete response (CR) or partial response (PRO), confirmed or unconfirmed.'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'From first dose of study drug until progressive disease, death or last assessment contact, whichever comes first, an average of 1-2 years', 'description': 'Progression-free survival (PFS) defined as the duration from the first study dose of study drug until progressive disease, death or last assessment contact whichever comes first.'}, {'measure': 'Overall Survival', 'timeFrame': 'from the first dose of study drug until death, last observation or contact, an average of 1-2 years', 'description': 'Overall Survival (OS) is defined as the time from the first dose of study drug until death due to any cause or last observation or contact.'}, {'measure': 'Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0', 'timeFrame': 'Initiation through 30 days following the last administration of study treatment.', 'description': 'Toxicity will be estimated by the number of Grade ≥ 3 as determined by CTCAE v 5.0.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the combination of the three anti-cancer drugs carboplatin, paclitaxel, and ramucirumab is helpful in shrinking tumors or delaying tumor growth in participants with non-small cell lung cancer. This study will also assess whether it is safe to combine these drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older\n* Prior exposure to 4-6 cycles of Pem/Carbo/Pembro and PD after at least 18 weeks of maintenance Pemetrexed, Pembrolizumab or the combination of the two.\n* PS 0-1\n\nExclusion Criteria:\n\n* Presence of a driver mutation that is susceptible to targeted therapy\n* Other active invasive malignancy requiring ongoing therapy\n* Grade 2 or higher sensory neuropathy\n* Evidence of untreated brain metastases\n* History of bleeding diatheses or recent, antecedent hemoptysis (\\> 1/2 teaspoon in prior 2 months)'}, 'identificationModule': {'nctId': 'NCT04332367', 'briefTitle': 'Carboplatin, Taxane And Ramucirumab for Patients With NSCLC After Pemetrexed or Pembrolizumab Maintenance', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Phase II, Single-Arm Study Of Carboplatin, Weekly Taxane, And Ramucirumab In Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After Progressive Disease On Maintenance Pemetrexed And/Or Pembrolizumab', 'orgStudyIdInfo': {'id': 'UPCC 05519'}, 'secondaryIdInfos': [{'id': 'IRB833759', 'type': 'OTHER', 'domain': 'University of Pennsylvania'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carboplatin, Taxane And Ramucirumab', 'description': 'Carboplatin AUC 5 IV every 3 wks, Paclitaxel 80 mg/m2 IV days 1 and 8 every 3 weeks, and Ramucirumab 10 mg/kg IV every 3 weeks', 'interventionNames': ['Drug: Carboplatin', 'Drug: Paclitaxel', 'Drug: Ramucirumab']}], 'interventions': [{'name': 'Carboplatin', 'type': 'DRUG', 'otherNames': ['Paraplatin'], 'description': 'Carboplatin IV', 'armGroupLabels': ['Carboplatin, Taxane And Ramucirumab']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Abraxane, Taxol'], 'description': 'Paclitaxel IV', 'armGroupLabels': ['Carboplatin, Taxane And Ramucirumab']}, {'name': 'Ramucirumab', 'type': 'DRUG', 'otherNames': ['Cyramza'], 'description': 'Ramucirumab IV', 'armGroupLabels': ['Carboplatin, Taxane And Ramucirumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melissa Volpe', 'role': 'CONTACT', 'email': 'Melissa.volpe@pennmedicine.upenn.edu', 'phone': '215-220-9703'}], 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Melissa Volpe, BA', 'role': 'CONTACT', 'email': 'Melissa.volpe@pennmedicine.upenn.edu', 'phone': '215-220-9703'}, {'name': 'Melina Marmarelis, MD', 'role': 'CONTACT', 'phone': '267-438-8154'}], 'overallOfficials': [{'name': 'Melina Marmarelis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Abramson Cancer Center at Penn Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}