Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT03823118
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2019-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2019-01-28', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'each 21 days up to the toxicity or PD (up to 6 months)', 'description': 'measured by Response Evaluation Criteria in Solid Tumors version 1.1'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': 'Duration of time from the start of treatment to the first documented disease progression according to RECIST 1.1 or death due to any cause, whichever occurs first, assessed up to 12 months', 'description': 'PFS will be estimated using standard Kaplan Meier survival analysis methods.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Duration of time from the start of treatment to date of death, assessed up to 2 years', 'description': 'OS will be estimated using standard Kaplan Meier survival analysis methods.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 2 years', 'description': 'Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Cancer Recurrent']}, 'referencesModule': {'references': [{'pmid': '39333988', 'type': 'DERIVED', 'citation': 'Wang W, Wu G, Luo W, Lin L, Zhou C, Yao G, Chen M, Wu X, Chen Z, Ye J, Yang H, Lv D. Anlotinib plus oral fluoropyrimidine S-1 in refractory or relapsed small-cell lung cancer (SALTER TRIAL): a multicenter, single-arm, phase II trial. BMC Cancer. 2024 Sep 27;24(1):1182. doi: 10.1186/s12885-024-12954-8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence after at least one standard chemotherapy.', 'detailedDescription': 'Although SCLC is very responsive to initial treatment, most patients relapse with relatively resistant disease.These patients have a median survival of only 4 to 5 months when treated with further systemic therapy. Improvements in therapy for relapsed SCLC are much needed.The purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence after at least one standard chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytologically confirmed small cell lung cancer;\n* Systemic chemotherapy that has previously received at least one or more lines regimen, followed by disease progression or recurrence;\n* Age 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months\n* participants had at least one measurable target lesion by RECIST1.1\n* The main organ function meets the following criteria:absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥80 × 109 / L, hemoglobin ≥ 80 g / L;total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;\n* Patients should participate in the study voluntarily and sign informed consent\n\nExclusion Criteria:\n\n* Patients who have been used anti-angiogenesis inhibitors,such as (such as sunitinib,bevacizumab,endostar et al.\n* Subjects with symptomatic brain metastases;\n* Patients whose primary lesion with active bleeding within 4 months\n* Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg\n* Patients with active or unable to control serious infections\n* Patients who are pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT03823118', 'briefTitle': 'S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Taizhou Hospital'}, 'officialTitle': 'S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer：An One-arm, Phase Ⅱ, Multi-center Clinical Study (SALTER TRIAL)', 'orgStudyIdInfo': {'id': 'SALTER Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S1/Anlotinib', 'description': 'Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.', 'interventionNames': ['Drug: S1/Anlotinib']}], 'interventions': [{'name': 'S1/Anlotinib', 'type': 'DRUG', 'description': 'Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.', 'armGroupLabels': ['S1/Anlotinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '317000', 'city': 'Taizhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Taizhou Hospital, Wenzhou Medical University', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}, {'city': 'Taizhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Enze Hospital', 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}, {'city': 'Taizhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Sanmen People's Hospital", 'geoPoint': {'lat': 28.66266, 'lon': 121.43312}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taizhou Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Radiation Oncology', 'investigatorFullName': 'Haihua Yang', 'investigatorAffiliation': 'Taizhou Hospital'}}}}