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NCT05879068Active, not recruitingPhase 2

A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC

A Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Paclitaxel Injection as Second Line Treatment for Small Cell Lung Cancer(SCLC)

Source: ClinicalTrials.gov · Last updated 18 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
99 (estimated)
First submitted
17 May 2023
Start date
27 May 2022
Primary completion date
30 Apr 2025
Lead sponsor
Biotheus Inc.
Diseases
Lung cancer
NCT number
NCT05879068

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 99
  • From 27 May 2022 to the primary completion date, 30 Apr 2025
  • 11 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
  • Evidence and history of severe bleeding tendency;
  • History of severe cardiovascular diseases within 6 months;
  • Current presence of severe superior vena cava syndrome and spinal cord compression;
  • History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
  • History of alcohol abuse, psychotropic substance abuse or drug abuse;
  • Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
  • Other conditions considered unsuitable for this study by the investigator.

Other

  • Current presence of uncontrolled pleural, pericardial, and peritoneal effusions;
  • Pregnant or lactating women;

Who the study is looking for

  • Signed informed consent form before any trial-related processes;
  • Age ≥18 years;
  • Histologically or cytologically confirmed SCLC;
  • Advanced SCLC who failed first-line platinum-based chemotherapy with or without checkpoint inhibitors;
  • Have adequate organ function;
  • The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
  • Life expectancy of ≥12 weeks;
  • Had at least one measurable tumor lesion according to RECIST v1.1.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University Cancer Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Jilin Provincial Tumor Hospital
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Hunan Cancer Hospital
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
Sichuan Provincial People's Hospital
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Zhejiang Provincial People's Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
Coordinator of this site? Confirm its status
HarbinChinaUnknown status
Shandong Cancer Hospital
Coordinator of this site? Confirm its status
JinanChinaUnknown status
The First Affiliated Hospital of NanChang University
Coordinator of this site? Confirm its status
NanchangChinaUnknown status
Shanghai Pulmonary Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
Coordinator of this site? Confirm its status
Xi’anChinaUnknown status
Henan Cancer Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.