Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-27 @ 6:34 AM
Study NCT ID:
NCT02924233
Status:
WITHDRAWN
Last Update Posted:
2017-08-28
First Post:
2016-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'C569270', 'term': 'futuximab'}, {'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'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': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Symphogen made a business decision to no longer perform the clinical study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-25', 'studyFirstSubmitDate': '2016-09-28', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b: Determination of the Dose-Limiting Toxicities (DLT) and the MTD and/or RP2D of escalating doses of Sym004 in combination with a standard dose of nivolumab', 'timeFrame': '1 year'}, {'measure': 'Phase 2b: Evaluation of the antitumor effects of the RP2D of Sym004 when administered in combination with a standard dose of nivolumab as measured by Response Rate', 'timeFrame': '1.5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Squamous', 'Non-Small Cell Lung Cancer', 'NSCLC'], 'conditions': ['Squamous Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase 1b/2b study investigating the safety and preliminary antitumor effects of Sym004 in combination with nivolumab versus nivolumab monotherapy when administered every second week.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Signed and dated written informed consent\n* Male or female ≥18 years of age at the time of informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy \\>3 months assessed during Screening\n* Histologically or cytologically confirmed, locally advanced or metastatic squamous NSCLC\n\nMain Exclusion Criteria:\n\n* Any antineoplastic agent (standard or investigational) within 2 weeks prior to starting trial treatment\n* Radiosurgery or radiotherapy for target lesions within 2 weeks prior to starting trial treatment\n* Prophylactic use of hematopoietic growth factors within 1 week prior to starting trial treatment\n* Active Central Nervous System (CNS) metastases or carcinomatous meningitis\n* Women who are pregnant\n* Women who are breastfeeding'}, 'identificationModule': {'nctId': 'NCT02924233', 'briefTitle': 'Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Symphogen A/S'}, 'officialTitle': 'An Open-label, Randomized, Multicenter, Phase 1b/2b Trial Investigating the Safety and Preliminary Antitumor Effects of Sym004 in Combination With Nivolumab Versus Nivolumab Monotherapy in EGFR-amplified Squamous Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'Sym004-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sym004 + nivolumab', 'description': 'Phase 1b, dose-escalation:\n\nDose Level 1: Sym004 + nivolumab (Q2W)\n\nDose Level 2: Sym004 + nivolumab (Q2W)\n\nDose Level -1: Sym004 + nivolumab, if needed', 'interventionNames': ['Drug: Sym004', 'Drug: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Sym004 (RP2D) + nivolumab', 'description': 'Phase 2b, dose-expansion:\n\nReceiving Sym004 in the RP2D in combination with nivolumab (Q2W)', 'interventionNames': ['Drug: Sym004', 'Drug: Nivolumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nivolumab', 'description': 'Phase 2b, dose-expansion:\n\nReceiving nivolumab monotherapy (Q2W)', 'interventionNames': ['Drug: Nivolumab']}], 'interventions': [{'name': 'Sym004', 'type': 'DRUG', 'description': 'Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR).\n\nSym004 will be administered at different dose-levels via infusion Q2W', 'armGroupLabels': ['Sym004 (RP2D) + nivolumab', 'Sym004 + nivolumab']}, {'name': 'Nivolumab', 'type': 'DRUG', 'description': 'Nivolumab is a humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody. Nivolumab will be administered via 60-minute infusion Q2W', 'armGroupLabels': ['Nivolumab', 'Sym004 (RP2D) + nivolumab', 'Sym004 + nivolumab']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Symphogen A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}