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

CSPC Pharmaceutical Group

Status and phase: Terminated; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Drug: PLM60

Study type: Interventional

Funder types: Industry

Identifiers

NCT04352413

HE071-CSP-010

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

45 participants in 2 patient groups

Cohort A: PLM60

Experimental group

Description:

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

Treatment:

Drug: PLM60

Cohort B: PLM60

Experimental group

Description:

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

Treatment:

Drug: PLM60