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

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

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

Study Overview

• Status: Terminated
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: PLM60

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: PLM60; 20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle	Drug: PLM60; Administration: Intravenous infusion
Experimental: Cohort B: PLM60; 15mg/m2, 3 weeks/cycle, administered on day 1 of each cycle	Drug: PLM60; Administration: Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	To evaluate ORR in SCLC subjects treated with PLM60	Through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DoR)	To evaluate DoR in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Disease Control Rate (DCR)	To evaluate DCR in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Progression Free Survival (PFS)	To evaluate PFS in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Overall Survival (OS)	To evaluate OS in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Adverse Events	To evaluate the safety profiles in SCLC subjects treated with PLM60	Through study completion, an average of 2 year
Serious Adverse Events (SAEs)	To evaluate the safety profiles in SCLC subjects treated with PLM60	Through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Study Chair: Kun Lou, Department of Medicine, CSPC Clinical Development Division

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): April 29, 2022

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: HE071-CSP-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No