Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-24 @ 3:32 PM
Study NCT ID:
NCT03781869
Status:
UNKNOWN
Last Update Posted:
2018-12-20
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'D005047', 'term': 'Etoposide'}, {'id': 'D002945', 'term': 'Cisplatin'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-18', 'studyFirstSubmitDate': '2018-12-18', 'studyFirstSubmitQcDate': '2018-12-18', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'From randomization，each 42 days up to PD or death(up to 24 months', 'description': 'The first day of treatment to the date that disease progression is reported'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From randomization until death (up to 5 years)', 'description': 'The first day of treatment to death or last survival confirm date'}, {'measure': 'Objective Response Rate', 'timeFrame': 'each 42 days up to intolerance the toxicity or PD (up to 24 months)'}, {'measure': 'Treatment-related adverse events', 'timeFrame': 'the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months', 'description': 'Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.'}, {'measure': 'Performance Status', 'timeFrame': 'the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months', 'description': 'Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).'}, {'measure': 'Disease Control Rate', 'timeFrame': 'each 42 days up to intolerance the toxicity or PD (up to 24 months)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small Cell Lung Cancer; Anlotinib; Maintenance therapy'], 'conditions': ['Extensive-stage Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that, compared with placebo, Anlotinib could improve the patients survival and had less toxic side effects after 2-3 line therapy. The purpose of this multicenter, randomized, prospective study is to investigate the efficacy and safety of Anlotinib as the maintenance therapy for Extensive-stage small cell lung cancer after combined with etoposide and cisplatin chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologic or cytologic diagnosis of small cell lung caner\n* Advanced small cell lung cancer who had no prior cisplatin-based chemotherapy or radiotherapy,at least one measurable lesion (by RECIST1.1)\n* Males or females between 18 Years to 75 Years.\n* Performance status of 0～2 on the ECOG criteria.\n* Main organs function is normal\n* Expected survival is above three months.\n* with asymptomatic brain metastases.\n* At least one measurable lung tumor lesion (according to RECIST criteria, the application of conventional technology, diameter length of the lesion \\>= 20mm or spiral CT \\>=10mm).\n* Adequate hematologic (Leukocyte count \\>= 4.0×109/L, neutrophil count\\>=2.0×109/L, hemoglobin\\>=95g/L, platelets\\>=100×109/L), hepatic function (aspartate transaminase (AST) \\& alanine transaminase(ALT)\n\n =\\<upper normal limit(UNL) x1.5, bilirubin level =\\< UNL x 1.5).\n* Patient can take oral medicine.\n* Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.\n\nExclusion Criteria:\n\n* History of cardiovascular disease: congestive heart failure (CHF) \\> New York Heart Association (NYHA) II, active coronary artery disease(patients with myocardial infarction six months ago can be recruited), arrhythmias need to be treated (allow taking beta blockers or digoxin).\n* Serious clinical infection (\\> NCI-CTCAE version 4.0 ,infection standard II).\n* Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).\n* The patients had accepted allogeneic organ transplantation.\n* Bleeding tendency or coagulation disorders.\n* patients who need renal dialysis.\n* suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured basal cell carcinoma, cured bladder epithelial tumor).\n* uncontrolled hypertension (systolic pressure\\>150 mmHg , or diastolic pressure\\> 90 mmHg).\n* thrombosis or embolism(cerebrovascular accidents including transient ischemic attack within the last 6 months).\n* pulmonary hemorrhage \\>CTCAE grade 2 within 4 weeks before first use of drugs.\n* Other organ hemorrhage \\>CTCAE grade 3 within 4 weeks before first use of drugs.\n* severe uncured wounds, ulcers or fracture.\n* uncured dehydration.\n* Drugs abuse and medical, psychological or social conditions may interfere with the patient's participation in research or the results of the evaluation effect.\n* Patients are allergic to drugs used in research.\n* Factors influencing the safety and compliance of patients.\n* Inability to comply with protocol or study procedures.\n* Pregnant or breast-feeding.\n* The researcher believe that the Patient is not suitable to participate in the study."}, 'identificationModule': {'nctId': 'NCT03781869', 'briefTitle': 'Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Third Military Medical University'}, 'officialTitle': 'A Randomized Controlled Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy', 'orgStudyIdInfo': {'id': 'ALT-SCLC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anlotinib + Chemotherapy', 'description': 'Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, and Anlotinib 12mg/d on day 1 to day 14 , repeated every 21 days, a total of 4-6 cycles, and then continue to take Anlotinib 12mg/d on day 1 to day 14, repeated every 21 days until progressive Disease(PD).', 'interventionNames': ['Drug: Anlotinib Hydrochloride; etoposide and cisplatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Chemotherapy', 'description': 'Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, repeated every 21 days, a total of 4-6 cycles, and then follow up observation until PD.', 'interventionNames': ['Drug: etoposide and cisplatin']}], 'interventions': [{'name': 'Anlotinib Hydrochloride; etoposide and cisplatin', 'type': 'DRUG', 'description': 'etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1 and Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, repeated every 21 days', 'armGroupLabels': ['Anlotinib + Chemotherapy']}, {'name': 'etoposide and cisplatin', 'type': 'DRUG', 'description': 'etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days', 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dong Wang, PH.D.', 'role': 'CONTACT', 'email': 'dongwang64@hotmail.com', 'phone': '86-23-68757151'}], 'overallOfficials': [{'name': 'Dong Wang, PH.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daping Hospital, Third Military Medical University, Chongqing,China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Military Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Dong Wang', 'investigatorAffiliation': 'Third Military Medical University'}}}}