Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-02 @ 6:10 PM
Study NCT ID:
NCT03389256
Status:
UNKNOWN
Last Update Posted:
2018-01-03
First Post:
2017-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Apatinib in the Treatment of Patients With EGFR T790M-Negative NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C553458', 'term': 'apatinib'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-26', 'studyFirstSubmitDate': '2017-12-26', 'studyFirstSubmitQcDate': '2017-12-26', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to 24 months', 'description': 'the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'up to 36 months', 'description': 'The length of time from either the date of diagnosis or the start of treatment that half of the patients in a group of patients diagnosed with the disease are still alive.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'up to 24 months', 'description': 'From first response to the date of first documented disease progression'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': '24 weeks', 'description': 'the proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator.'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': '24 weeks', 'description': 'the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator'}, {'measure': 'the quality of life (QoL)', 'timeFrame': 'up to 36 months', 'description': 'Analysis of changes from baseline using the quality of life (QoL) instrument'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['apatinib', 'T790 negative', 'NSCLC'], 'conditions': ['Lung Diseases', 'Neoplasms', 'Respiratory Tract Diseases', 'Thoracic Neoplasms', 'Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'This phase 2 study is designed to evaluate the safety and activity of apatinib,a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2, in combination with EGFR-TKI in NSCLC with T790M-negative after the failure of EGFR-TKI therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically confirmed stage IIIB, IV non-squamous non-small cell lung cancer, with measurable lesions (the long axis of tumor lesions ≥ 10mm with CT, the short axis of lymph node lesions ≥ 15mm with CT, the lesions not receive radiotherapy, frozen or other local treatment);\n* Patients with slow progression on first-line EGFR TKI(erlotinib / icotinib / gefitinib) treatment;\n* No T790M mutation including an assessment from tumor biopsy obtained while on or subsequent to the most recent EGFR TKI therapy;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2;\n* Life expectancy of more than 3 months;\n* Adequate bone marrow function: WBC ≥ 3.0 ×10 E+9/L, neutrophil ≥ 1.5 × 10 E+9/L, platelets ≥ 80 × 10E+9/L,Hb ≥ 10.0g/dL;a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL), a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤3UNL or ≤5UNL in case of liver metastasis, a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault);\n* Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug;\n* the participants volunteered to join this study should sign the informed consent forms, have better compliance in the follow-up;\n\nExclusion Criteria:\n\n* Squamous cell carcinoma (including adenosquamous carcinoma); Small cell lung carcinoma (including small cell carcinoma and non-small cell mixed lung carcinoma);\n* Active brain metastases, cancerous meningitis, patients with spinal cord compression;\n* Rapid progression of the disease or cancer invades vital organs;\n* The distance between the tumor lesion and the large blood vessel is less than 5 mm, or there is a central tumor invading local macrovascular;\n* obvious pulmonary cavity or tumor necrosis;\n* Uncontrollable high blood pressure;\n* Grade Ⅱ or above myocardial ischemia or myocardial infarction or arrhythmia control is not good,Ⅲ \\~ Ⅳ grade cardiac insufficiency, or cardiac ultrasonography showed left ventricular ejection fraction (LVEF) \\<50% according to the NYHA standard;\n* Have a history of interstitial lung disease or patients with interstitial lung disease;\n* Coagulation abnormalities (INR\\> 1.5 or PT\\> ULN + 4s or APTT\\> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;\n* There was significant hemoptysis within 2 months prior to enrollment, or a daily hemoptysis volume is 2.5 ml or above;\n* A clinically significant bleeding symptom or bleeding tendencies such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above, or vasculitis that occurred within 3 months prior to enrollment;\n* Aneurysm / venous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;\n* Arterial / venous thrombotic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism within 12 months prior to enrollment;\n* Hereditary or acquired bleeding and thrombophilia, such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism；\n* Long-term unhealed wounds or fractures;\n* Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks prior to enrollment;\n* Unable to swallow, chronic diarrhea or intestinal obstruction;\n* Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months prior to enrollment;\n* Urinary protein ≥ ++, 24-hour urinary protein ≥ 1.0 g;\n* Active infections require antimicrobial treatment;\n* ALK gene abnormalities (gene fusion or mutation occurred);\n* Pregnant or lactating women, or women unwilling or unable to take effective contraception;'}, 'identificationModule': {'nctId': 'NCT03389256', 'briefTitle': 'Apatinib in the Treatment of Patients With EGFR T790M-Negative NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan Cancer Hospital and Research Institute'}, 'officialTitle': 'A Randomized, Controlled Phase II Clinical Trial of Apatinib in Combination With EGFR-TKI Versus EGFR-TKI for Non-squamous, Non-small Cell Lung Cancer(NSCLC) With T790M-negative After the Failure of EGFR-TKI Therapy', 'orgStudyIdInfo': {'id': 'APTN-NSCLC-201712'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'apatinib combine with EGFR-TKI', 'description': 'Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity', 'interventionNames': ['Drug: Apatinib', 'Drug: EGFR-TKI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EGFR-TKI', 'description': 'Every 4 weeks 1 cycle, evaluated the efficacy and safety once every 2 cycles, treat until disease progression or intolerable toxicity', 'interventionNames': ['Drug: EGFR-TKI']}], 'interventions': [{'name': 'Apatinib', 'type': 'DRUG', 'otherNames': ['apatinib tablets'], 'description': 'Apatinib mesylate tablets 250 mg qd po, if the patient can tolerate the toxic side effects, adjust the dose to 500mg qd po after 1 week.', 'armGroupLabels': ['apatinib combine with EGFR-TKI']}, {'name': 'EGFR-TKI', 'type': 'DRUG', 'otherNames': ['Imatinib、Gefitinib or Erlotinib'], 'description': 'Imatinib tablets, 125 mg tid po; gefitinib tablets, 250 mg qd po; erlotinib tablets, 150 mg qd po', 'armGroupLabels': ['EGFR-TKI', 'apatinib combine with EGFR-TKI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Sichuan Cancer Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Panwen Tian, MD', 'role': 'CONTACT', 'phone': '+8618036675920'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610071', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Rui Ao, MD', 'role': 'CONTACT', 'email': 'aorui1040@hotmail.com', 'phone': '+8618036675290'}], 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Juan Li, MD', 'role': 'CONTACT', 'email': 'dr.lijuan@gmail.com', 'phone': '+8613880276636'}, {'name': 'Rui Shi, MD', 'role': 'CONTACT', 'email': 'shirui729@hotmail.com', 'phone': '+8613880898008'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Cancer Hospital and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Juan LI, MD', 'investigatorAffiliation': 'Sichuan Cancer Hospital and Research Institute'}}}}