PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second‑line Treatment in Small Cell Lung Cancer

Trial status:Recruitment Complete
Trial ID:
PM8002-C014C-SCLC-R
NCT ID:
NCT06616532
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 will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel as second-line treatment for SCLC

Medical Condition
Unmapped
Study Drug
PM8002
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Paclitaxel
Topotecan
Phase
Phase 3
Type
Interventional
Estimated Enrolment
404
Estimated Trial Date
Nov 2024 - Jan 2027

Trial Participant Requirements

Age
18 - 75 Years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion Criteria
Inclusion criteria
  1. Voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures;
  2. Age ≥18 years but ≤75 years;
  3. Histologically or cytologically confirmed SCLC;
  4. Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors);
  5. Having adequate organ functions;
  6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
  7. Life expectancy of 12 weeks or more;
  8. Having at least one measurable tumor lesion according to RECIST v1.1;
Exclusion criteria
  1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
  2. Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs;
  3. Current presence of severe superior vena cava syndrome and spinal cord compression;
  4. Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;
  5. Evidence of significant clotting disorder or other significant bleeding risk;
  6. History of severe, uncontrollable, or active cardiovascular diseases within 6 months;
  7. Current presence of uncontrollable pleural, pericardial, and peritoneal effusions;
  8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
  9. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
  10. History of alcohol abuse, psychotropic substance abuse or drug abuse;
  11. Pregnant or lactating women;
  12. Other conditions considered unsuitable for this study by the investigator.

Trial Locations

Location
Status
Location
Binzhou Medical University Hospital
Binzhou, China
Status
Location
Jilin Cancer Hospital
Changchun, China
Status
Location
Hunan Cancer Hospital
Changsha, China
Status
Location
Sichuan Cancer Hospital
Chengdu, China
Status
Location
First People's Hospital of Chenzhou
Chenzhou, China
Status
Location
The First Affiliated Hospital of Army Medical University
Chongqing, China
Status
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