Search / Trial NCT06616532

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

Launched by BIOTHEUS INC. · Sep 25, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Second Line

ClinConnect Summary

This clinical trial is studying a new treatment for small cell lung cancer (SCLC), specifically looking at the combination of a drug called PM8002 with Paclitaxel. PM8002 is a special type of medication designed to target specific proteins that can help cancer grow. This trial is aimed at patients who have already received chemotherapy and whose cancer has either progressed or come back. It’s a Phase 3 trial, which means researchers are testing how well this new treatment works compared to standard chemotherapy in patients whose cancer has not improved with earlier treatments.

To be eligible for this study, participants need to be between 18 and 75 years old and have a confirmed diagnosis of advanced SCLC. They should have experienced cancer progression after their first treatment and have a good performance status, meaning they are generally able to carry out daily activities without much difficulty. Participants can expect to undergo various tests to monitor their health and the effectiveness of the treatment throughout the study. It’s important to note that certain medical conditions and previous treatments may exclude potential participants from joining the trial. If you or someone you know is interested in this study, it's a good idea to talk to a healthcare provider for more information.

Gender

ALL

Eligibility 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 Officials

Ying Cheng

Principal Investigator

Jilin Provincial Tumor Hospital

About Biotheus Inc.

Biotheus Inc. is a leading biotechnology company dedicated to advancing innovative therapies in the field of immuno-oncology and autoimmune diseases. Focused on the development of novel monoclonal antibodies and biologics, Biotheus harnesses cutting-edge technologies to address unmet medical needs and improve patient outcomes. With a robust pipeline of clinical-stage products, the company is committed to rigorous research and development processes, ensuring the highest standards of safety and efficacy. Through strategic collaborations and a patient-centric approach, Biotheus aims to transform the landscape of targeted therapies and contribute to the future of personalized medicine.

Locations

Nanjing, , China

Xuzhou, , China

Changchun, , China

Foshan, , China

Nanchang, Jiangxi, China

Wuhan, , China

Hangzhou, , China

Changsha, , China

Wuhan, , China

Changchun, Jilin, China

Hefei, , China

Nantong, Jiangsu, China

Fuzhou, , China

Xi'an, , China

Nanyang, , China

Zhangzhou, , China

Chengdu, , China

Harbin, , China

Kunming, , China

Dalian, , China

Luoyang, , China

Weihai, , China

Chongqing, , China

Shijia Zhuang, , China

Nanchong, , China

Nanning, , China

Nanchang, , China

Xiangyang, , China

Changchun, , China

Mianyang, , China

Binzhou, , China

Jining, , China

Meizhou, , China

Ningbo, Zhejiang, China

Chenzhou, , China

Yibin, , China

Liuzhou, , China

Guilin, , China

Jinan, , China

Jingzhou, , China

Nanjing, , China

Qujing, , China

Taizhou, , China

Weifang, , China

Yongzhou, , China

Yuncheng, , China

Zhoukou, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0