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

Trial status:Recruitment Complete
Trial ID:
PM8002-BC010C-NSCLC-R
NCT ID:
NCT05756972
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 is a phase II study to evaluate the efficacy and safety of PM8002 in combination with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have failed to EGFR-TKI treatment.

Medical Condition
Unmapped
Study Drug
PM8002
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Carboplatin
Pemetrexed
Phase
Phase 2
Type
Interventional
Estimated Enrolment
64
Estimated Trial Date
Jun 2023 - Sep 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 male or female.
  3. Have a histologically or cytologically confirmed stage IIIB/IIIC NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic non-squamous NSCLC (IV).
  4. with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment.
  5. EGFR-TKI resistance, confirmed by RECIST v1.1.
  6. have adequate organ function.
  7. The investigator confirms at least one measurable lesion according to RECIST v1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed.
  8. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
Exclusion criteria
  1. Squamous cell \> 10%. If small cell types are present, the subject is not eligible for inclusion.
  2. Have other driving gene mutations that can obtain effective treatment.
  3. Have previously received systemic anti-tumor treatment other than EGFR-TKI for advanced non-squamous NSCLC.
  4. Have received systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study drugs.
  5. Have received EGFR-TKI treatment, within 14 days prior to the first dose of study drugs
  6. Anticoagulant or thrombolytic agent within 10 days prior to the first dose of study drugs.
  7. Evidence and history of severe bleeding tendency or coagulation dysfunction.
  8. The toxicity of previous anti-tumor therapy has not been alleviated.
  9. Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.
  10. Have suffered from the second primary active malignant tumor in the past 5 years.

Trial Locations

Location
Status
Location
Medical Ethics Committee of Guangdong Provincial People's Hospital
Guangzhou, Guangdonng, China, 519041
Status