A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
Primary Purpose
Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PLM60
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- West China Hospital of Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort A: PLM60
Cohort B: PLM60
Arm Description
20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle
15mg/m2, 3 weeks/cycle, administered on day 1 of each cycle
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
To evaluate ORR in SCLC subjects treated with PLM60
Secondary Outcome Measures
Duration of Response (DoR)
To evaluate DoR in SCLC subjects treated with PLM60
Disease Control Rate (DCR)
To evaluate DCR in SCLC subjects treated with PLM60
Progression Free Survival (PFS)
To evaluate PFS in SCLC subjects treated with PLM60
Overall Survival (OS)
To evaluate OS in SCLC subjects treated with PLM60
Adverse Events
To evaluate the safety profiles in SCLC subjects treated with PLM60
Serious Adverse Events (SAEs)
To evaluate the safety profiles in SCLC subjects treated with PLM60
Full Information
NCT ID
NCT04352413
First Posted
April 14, 2020
Last Updated
July 29, 2020
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04352413
Brief Title
A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
Official Title
An Open-label, Multi-center, Phase 2 Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection (PLM60) in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
January 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 explore the safety and PK characteristics of PLM60
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort A: PLM60
Arm Type
Experimental
Arm Description
20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle
Arm Title
Cohort B: PLM60
Arm Type
Experimental
Arm Description
15mg/m2, 3 weeks/cycle, administered on day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
PLM60
Intervention Description
Administration: Intravenous infusion
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
To evaluate ORR in SCLC subjects treated with PLM60
Time Frame
Through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
Duration of Response (DoR)
Description
To evaluate DoR in SCLC subjects treated with PLM60
Time Frame
Through study completion, an average of 2 year
Title
Disease Control Rate (DCR)
Description
To evaluate DCR in SCLC subjects treated with PLM60
Time Frame
Through study completion, an average of 2 year
Title
Progression Free Survival (PFS)
Description
To evaluate PFS in SCLC subjects treated with PLM60
Time Frame
Through study completion, an average of 2 year
Title
Overall Survival (OS)
Description
To evaluate OS in SCLC subjects treated with PLM60
Time Frame
Through study completion, an average of 2 year
Title
Adverse Events
Description
To evaluate the safety profiles in SCLC subjects treated with PLM60
Time Frame
Through study completion, an average of 2 year
Title
Serious Adverse Events (SAEs)
Description
To evaluate the safety profiles in SCLC subjects treated with PLM60
Time Frame
Through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Lou
Phone
0311-67808817
Email
loukun@mail.ecspc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuefang Xia
Phone
010-63930702
Email
xiaxuefang@mail.ecspc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Lou
Organizational Affiliation
Department of Medicine, CSPC Clinical Development Division
Official's Role
Study Chair
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhou
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy
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