Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-17 @ 10:05 PM
Study NCT ID:
NCT03634059
Status:
UNKNOWN
Last Update Posted:
2018-08-16
First Post:
2018-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C553458', 'term': 'apatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2018-07-12', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'evaluated in two years since the treatment began', 'description': 'Baseline to measured date of progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'tumor assessment every 8 weeks，up to two years', 'description': 'Baseline to measured stable disease'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'tumor assessment every 8 weeks，up to two years', 'description': 'Baseline to measured progressive disease'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'the first day of treatment to death or last survival confirm date，up to two years', 'description': 'Baseline to measured date of death from any cause'}, {'measure': 'Adverse events', 'timeFrame': 'evaluated in the two years since the treatment began according to the Common Terminology Criteria for Adverse Events Version 4.0', 'description': 'throughout study'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NSCLC']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of apatinib plus EGFR-TKI as first line treatment in patients with non-squamous NSCLC harboring EGFR mutation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age:18 to 75 years old (man or female);\n2. Pathologically diagnosed with non-squamous NSCLC;\n3. Imageology diagnosed with locally advanced/metastatic or recurrent (stage ⅢB - IV);\n4. Histologically or cytologic confirmed，harboring an activating EGFR mutation (19del or 21 L858R);\n5. None previous chemotherapy or targeted therapy.（NOTE: neoadjuvant and adjuvant therapy is allowed）;\n6. At least one measurable lesion (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1)；\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n8. Major organ function has to meet the following criteria:\n\n 1. HB≥90g/L；\n 2. ANC≥1.5×109/L；\n 3. PLT≥80×109/L；\n 4. ALT and AST≤2.5ULN, but≤5ULN if the transferanse elevation is due to liver metastases;\n 5. TBIL≤1.5ULN;\n 6. Serum creatinine≤1.25ULN; Endogenous creatinine clearance rate\\>45 ml/min;\n9. Life expectancy greater than or equal to 3 months;\n10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;\n11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.\n\nExclusion Criteria:\n\n1. Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg);\n2. Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\\<50%;\n3. Radiologically documented evidence of major blood vessel invasion or encasement by cancer;\n4. A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);\n5. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (++). Has melena and hematemesis in two months;\n6. Coagulant function abnormality (INR \\> 1.5 ULN, APTT \\> 1.5 ULN), with bleeding tendency;\n7. Patients with pregnant or planning a pregnancy;\n8. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ);\n9. History of psychiatric drugs abuse and can't quit or patients with mental disorders;\n10. Less than 4 weeks from the last clinical trial;\n11. The researchers think inappropriate."}, 'identificationModule': {'nctId': 'NCT03634059', 'briefTitle': 'A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Fourth Hospital'}, 'officialTitle': 'A Study of Apatinib Plus EGFR-TKI as First Line Treatment in Patients With Non-squamous NSCLC Harboring EGFR Mutations', 'orgStudyIdInfo': {'id': 'HRA-L01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'apatinib', 'description': 'apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po', 'interventionNames': ['Drug: Apatinib']}], 'interventions': [{'name': 'Apatinib', 'type': 'DRUG', 'description': 'apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po', 'armGroupLabels': ['apatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'contacts': [{'name': 'Junfeng Liu, Professor', 'role': 'CONTACT', 'email': '13931152296@126.com', 'phone': '13931152296'}], 'facility': 'Junfeng Liu', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}], 'centralContacts': [{'name': 'Junfeng Liu, Professor', 'role': 'CONTACT', 'email': '13931152296@126.com', 'phone': '13931152296'}, {'name': 'Junfeng Liu', 'role': 'CONTACT', 'email': '13931152296@126.com', 'phone': '13931152296'}], 'overallOfficials': [{'name': 'Junfeng Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Medical University Fourth Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'LiuJunFeng', 'investigatorAffiliation': 'Hebei Medical University Fourth Hospital'}}}}