Last updated: December 22, 2020
Sponsor: Shanghai Chest Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Small Cell Lung Cancer
Treatment
N/AClinical Study ID
NCT04684017
KS2039
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- According to the 8th edition of the AJCC/UICC TNM staging system for NSCLC, patientswith extensive stage SCLC confirmed by histology or cytology and are confirmed to haveat least one measurable lesion according to RECIST 1.1.
- Without active brain metastasis
- Previously treated with ICIs with progressive disease.
- Age ≥18 years and ≤75 years;
- ECOG PS score: 0 to 1
- The main organs function is normal, that is, the following criteria met: goodhematopoietic function, defined as absolute neutrophil count ≥1.5×109 /L, plateletcount≥100 ×109 /L, hemoglobin ≥90g/L [no blood transfusion or no erythropoietin (EPO)dependence within 7 days before enrollment]; biochemical test results should meet thefollowing criteria: BIL < 1.25 times the upper limit of normal value (ULN); ALT andAST < 2.5 × ULN; in case of liver metastases, ALT and AST < 5 × ULN; Cr ≤1.5×ULN orcreatinine clearance (CCr) ≥60ml/min; Coagulation function is good, INR and PT ≤1.5times ULN; if the subject is receiving anticoagulant treatment, PT should be withinthe prescribed range of use of anticoagulant drugs;
- Women of child-bearing age should agree to take contraceptive measures (such asintrauterine devices, contraceptives or condoms) during the study and within 6 monthsafter the study; non-breast-feeding patients whose serum or urinary pregnancy testshould be negative; male patients should agree to take contraceptive measures duringthe study and within 6 months after the study.
- Patients are voluntarily enrolled into the study, sign the informed consent form andhave good compliance.
Exclusion
Exclusion Criteria:
- Subjects with active CNS metastases are excluded.
- Non-small cell lung cancer.
- With obvious hemorrhage symptom
- Patients with many factors affecting oral medication, such as dysphagia,gastrointestinal resection, chronic diarrhea and intestinal obstruction.
- Combined with other tumors at the time of initial diagnosis.
- Patients who have previously participated in other clinical trials and have not yetterminated the trial.
- Patients who have acute infection that difficult to control.
Study Design
Total Participants: 29
Study Start date:
May 01, 2019
Estimated Completion Date:
January 01, 2022
Study Description
Connect with a study center
Shanghai Chest hospital
Shanghai, Shanghai 200030
ChinaActive - Recruiting

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