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

Phase 2

Terminated

• Conditions: Small Cell Lung Cancer
• Interventions: Drug: PLM60

• Registration Number: NCT04352413
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-20
• Study Start: 2020-06-18
• Primary Completion: 2022-01-30
• Study Completion: 2022-04-29
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort B: PLM60	PLM60	15mg/m2, 3 weeks/cycle, administered on day 1 of each cycle
Cohort A: PLM60	PLM60	20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China