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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: PLM60


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |