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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotheus Inc.
• Treatments: Atezolizumab; Etoposide

Criteria

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.