PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with paclitaxel as second line treatment for SCLC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Signed informed consent form before any trial-related processes;
2. Age ≥18 years;
3. Histologically or cytologically confirmed SCLC;
4. Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
5. Have adequate organ function;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Life expectancy of ≥12 weeks;
8. Had at least one measurable tumor lesion according to RECIST v1.1.
Exclusion Criteria:
1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
2. Evidence and history of severe bleeding tendency;
3. History of severe cardiovascular diseases within 6 months;
4. Current presence of severe superior vena cava syndrome and spinal cord compression;
5. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
6. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
7. History of alcohol abuse, psychotropic substance abuse or drug abuse;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
9. Pregnant or lactating women;
10. Other conditions considered unsuitable for this study by the investigator.
Primary outcome measure(s)
Objective Response Rate — Up to approximately 2 years Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Treatment related adverse events (TRAEs) — Up to 30 days after last treatment The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
Trial sites (11)
Facility
City
Region
Status
Peking University Cancer Hospital
Beijing
China
Jilin Provincial Tumor Hospital
Changchun
China
Hunan Cancer Hospital
Changsha
China
Sichuan Provincial People's Hospital
Chengdu
China
Zhejiang Provincial People's Hospital
Hangzhou
China
Harbin Medical University Cancer Hospital
Harbin
China
Shandong Cancer Hospital
Jinan
China
The First Affiliated Hospital of Nanchang University
Nanchang
China
Shanghai Pulmonary Hospital
Shanghai
China
The First Affiliated Hospital of Xi'an Jiaotong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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