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

NCT04352413 | Terminated Phase 2

• 1 other identifier: HE071-CSP-010
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  To evaluate ORR in SCLC subjects treated with PLM60

  Through study completion, an average of 2 year

Secondary Outcomes (6)

• Duration of Response (DoR)

  Through study completion, an average of 2 year

• Disease Control Rate (DCR)

  Through study completion, an average of 2 year

• Progression Free Survival (PFS)

  Through study completion, an average of 2 year

• Overall Survival (OS)

  Through study completion, an average of 2 year

• Adverse Events

  Through study completion, an average of 2 year

Study Arms (2)

Cohort A: PLM60

EXPERIMENTAL

20 mg/m2, 4 weeks/cycle, administered on day 1 of each cycle

Drug: PLM60

Cohort B: PLM60

EXPERIMENTAL

15mg/m2, 3 weeks/cycle, administered on day 1 of each cycle

Drug: PLM60

Interventions

PLM60 DRUG

Administration: Intravenous infusion

Cohort A: PLM60; Cohort B: PLM60

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kun Lou

  Department of Medicine, CSPC Clinical Development Division

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 20, 2020
• Study Start: June 18, 2020
• Primary Completion: January 30, 2022
• Study Completion: April 29, 2022
• Last Updated: March 7, 2024

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)