Status:
TERMINATED
A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is an open, multicenter phase II clinical study for PLM60. The primary aim of the study is to observe the initial efficacy of PLM60 in treatment of small cell lung cancer. The secondary aim is to...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of SCLC;
- Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of SCLC;
- ECOG performance status 0\~2;
- Measurable lesion according to RECIST v1.1;
- Life expectancy ≥ 12 weeks;
- Adequate organ function;
- Signed informed consent from the patient.
Exclusion
- Radical surgical treatment for primary small cell lung cancer;
- Any anti-tumor treatment received within 4 weeks before the first use of the study drug;
- Untreated or symptomatic central nervous system (CNS) metastases;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Those receiving treatment of adriamycin or other anthracyclines previously, with the total cumulative adriamycin (or adriamycin-equivalent) dose of \>360 mg/m2.
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04352413
Start Date
June 18 2020
End Date
April 29 2022
Last Update
March 7 2024
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China