PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study to evaluate the efficacy and safety of PM8002 in combination with etoposide and platinum in first-line treatment of extensive-stage small cell lung cancer
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 ES-SCLC;
4. No prior systemic therapy for ES-SCLC;
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. Histologically or cytologically confirmed mixed SCLC;
2. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
3. The toxicity of previous anti-tumor therapy has not been alleviated;
4. Have received anti-platelet therapy within 10 days prior to the first dose of the study drugs;
5. Evidence and history of severe bleeding tendency;
6. History of severe cardiovascular diseases within 6 months;
7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
8. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
9. History of alcohol abuse, psychotropic substance abuse or drug abuse;
10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
11. Pregnant or lactating women;
12. Other conditions considered unsuitable for this study by the investigator.
Primary outcome measure(s)
Objective response rate (ORR) — Up to approximately 2 years ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Trial sites (17)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
China
Jilin Cancer Hospital
Changchun
China
The First Affiliated Hospital of Chongqing Medical University
Chongqing
China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
China
Zhejiang Cancer Hospital
Hangzhou
China
Harbin Medical University Cancer Hospital
Harbin
China
Anhui Provincial Hospital
Hefei
China
Central Hospital Affiliated To Shandong First Medical University
Jinan
China
Hebei Petro China Central Hospital
Langfang
China
Linyi Cancer Hospital
Linyi
China
The First Affiliated Hospital of Nanchang University
Nanchang
China
The Affiliated Hospital of Qingdao University
Qingdao
China
Shandong Cancer Hospital
Shandong
China
Shanghai Pulmonary Hospital
Shanghai
China
Taizhou Hospital of Zhejiang Province
Taizhou
China
Tianjin Medical University General Hospital
Tianjin
China
The First Affiliated Hospital of Zhengzhou 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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