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Clinical Trials in China / NCT05844150
Active, not recruiting Phase 2

A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC

NCT05844150 · tracked via the Priya Life Science China tracker
Sponsor
Biotheus Inc.
Phase
Phase 2
Started
2023-06-01
Last updated
2025-03-12

Condition(s) studied

SCLC

Investigational drug(s) / intervention(s)

PM8002PlatinumEtoposide

PM8002: IV infusion

Platinum: IV infusion

Etoposide: IV infusion

Study summary

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)

Trial sites (17)

FacilityCityRegionStatus
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 Zhengzhou China

More Biotheus Inc. trials in China

Other trials for the same condition

Official registry record

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.

View NCT05844150 on ClinicalTrials.gov ↗ ← All trials in China