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

Sponsored by Biotheus Inc.

About this trial

Last updated 2 years ago

Study ID

PM8002-BC011C-SCLC-R

Status

Not yet recruiting

Type

Interventional

Phase

Phase 2/Phase 3

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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.

No

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.