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

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04352413
• Collaborator: (none)
• Enrollment: 81
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.4
• Patients Per Site Per Month: 4.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: PLM60	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jun 18, 2020
• Anticipated Primary Completion Date: Jan 30, 2022
• Anticipated Study Completion Date: Jan 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Objective response rate (ORR) [Through study completion, an average of 2 year]

   To evaluate ORR in SCLC subjects treated with PLM60

Secondary Outcome Measures

1. Duration of Response (DoR) [Through study completion, an average of 2 year]

   To evaluate DoR in SCLC subjects treated with PLM60

2. Disease Control Rate (DCR) [Through study completion, an average of 2 year]

   To evaluate DCR in SCLC subjects treated with PLM60

3. Progression Free Survival (PFS) [Through study completion, an average of 2 year]

   To evaluate PFS in SCLC subjects treated with PLM60

4. Overall Survival (OS) [Through study completion, an average of 2 year]

   To evaluate OS in SCLC subjects treated with PLM60

5. Adverse Events [Through study completion, an average of 2 year]

   To evaluate the safety profiles in SCLC subjects treated with PLM60

6. Serious Adverse Events (SAEs) [Through study completion, an average of 2 year]

   To evaluate the safety profiles in SCLC subjects treated with PLM60

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Sichuan University	Chengdu	Sichuan	China

Sponsors and Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Investigators

• Study Chair: Kun Lou, Department of Medicine, CSPC Clinical Development Division

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04352413
• Other Study ID Numbers: HE071-CSP-010
• First Posted: Apr 20, 2020
• Last Update Posted: Jul 31, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma

Study Results

No Results Posted as of Jul 31, 2020