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

Trial status:Recruitment Complete
Trial ID:
PM8002-BC011C-SCLC-R
NCT ID:
NCT05844150
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
N/A
Recruitment Complete

Trial Details

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

Medical Condition
Unmapped
Study Drug
PM8002
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Platinum
Etoposide
Phase
Phase 2
Type
Interventional
Estimated Enrolment
50
Estimated Trial Date
Jun 2023 - May 2024

Trial Participant Requirements

Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion 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.

Trial Locations

Location
Status
Location
Beijing Cancer Hospital
Beijing, China
Status
Location
Jilin Cancer Hospital
Changchun, China
Status
Location
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Status
Location
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Status
Location
Zhejiang Cancer Hospital
Hangzhou, China
Status
Location
Harbin Medical University Cancer Hospital
Harbin, China
Status
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