A Study of PLM60 in Subjects With Relapsed Small-cell Lung Cancer After Platinum-based First-Line Chemotherapy

Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04352413
• Other study ID #: HE071-CSP-010
• Status: Terminated
• Phase: Phase 2
• Start date: June 18, 2020
• Est. completion date: April 29, 2022

Study information

• Verified date: April 2020
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: April 29, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed diagnosis of SCLC;

2. Must have recurrence or progression after platinum-based first-line chemotherapy or chemoradiation therapy for the treatment of SCLC;

3. ECOG performance status 0~2;

4. Measurable lesion according to RECIST v1.1;

5. Life expectancy = 12 weeks;

6. Adequate organ function;

7. Signed informed consent from the patient.

Exclusion Criteria:

1. Radical surgical treatment for primary small cell lung cancer;

2. Any anti-tumor treatment received within 4 weeks before the first use of the study drug;

3. Untreated or symptomatic central nervous system (CNS) metastases;

4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;

5. History of serious systemic diseases;

6. History of serious autoimmune diseases;

7. Those receiving treatment of adriamycin or other anthracyclines previously, with the total cumulative adriamycin (or adriamycin-equivalent) dose of >360 mg/m2.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• PLM60
Administration: Intravenous infusion

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	To evaluate ORR in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Secondary	Duration of Response (DoR)	To evaluate DoR in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Secondary	Disease Control Rate (DCR)	To evaluate DCR in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Secondary	Progression Free Survival (PFS)	To evaluate PFS in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Secondary	Overall Survival (OS)	To evaluate OS in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Secondary	Adverse Events	To evaluate the safety profiles in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Secondary	Serious Adverse Events (SAEs)	To evaluate the safety profiles in SCLC subjects treated with PLM60	Through study completion, an average of 2 year