Small Cell Lung Cancer
Conditions
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
Interventions
DRUGPLM60
Administration: Intravenous infusion
Sponsors
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Through study completion, an average of 2 year | To evaluate ORR in SCLC subjects treated with PLM60 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Duration of Response (DoR) | Through study completion, an average of 2 year | To evaluate DoR 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 |
| Overall Survival (OS) | Through study completion, an average of 2 year | To evaluate OS in SCLC subjects treated with PLM60 |
Countries
China
Outcome results
None listed