Combination of PM8002 and Paclitaxel for treating advanced small cell lung cancer

A Multicenter, Open-lable, Randomized Phase III Study of PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

This study is testing if a new combination of a drug called PM8002 with Paclitaxel can help people with advanced small cell lung cancer who haven't responded to their first treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Biotheus Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 45 sites (Nantong, Jiangsu and 44 other locations)
• Trial ID: NCT06616532 on ClinicalTrials.gov

What this trial studies

This phase III clinical trial evaluates the efficacy and safety of PM8002, a bispecific antibody targeting PD-L1 and VEGF, in combination with Paclitaxel as a second-line treatment for patients with small cell lung cancer (SCLC). The study is multicenter, randomized, and open-label, comparing the new treatment regimen against the investigator's choice of either Topotecan or Paclitaxel. Participants must have advanced SCLC that has progressed after first-line platinum-based chemotherapy. The trial aims to determine if this combination can improve patient outcomes compared to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed advanced SCLC that has progressed after first-line chemotherapy.

Not a fit: Patients with a history of severe allergies to study drugs or those who have previously received Paclitaxel or Topotecan may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced small cell lung cancer who have limited treatment choices.

How similar studies have performed: Previous studies have shown promising results with similar bispecific antibody approaches in cancer treatment, indicating potential for success in this trial.

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.

Where this trial is running

Nantong, Jiangsu and 44 other locations

• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Not_yet_recruiting)
• Jilin Cancer Hospital — Changchun, Jilin, China (Recruiting)
• The First Affiliated Hospital Of Ningbo University — Ningbo, Zhejiang, China (Not_yet_recruiting)
• Binzhou Medical University Hospital — Binzhou, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, China (Not_yet_recruiting)
• Sichuan Cancer Hospital — Chengdu, China (Recruiting)
• First People's Hospital of Chenzhou — Chenzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Army Medical University — Chongqing, China (Not_yet_recruiting)
• The Second Hospital of Dalian Medical University — Dalian, China (Not_yet_recruiting)
• The First People's Hospital of Foshan — Foshan, China (Not_yet_recruiting)
• Fujian Cancer Hospital — Fuzhou, China (Recruiting)
• The Affiliated Hospital Of Guilin Medical University — Guilin, China (Not_yet_recruiting)
• Zhejiang Cancer Hospital — Hangzhou, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Harbin, China (Not_yet_recruiting)
• Anhui Province Hospital — Hefei, China (Not_yet_recruiting)
• Shandong Cancer Institute — Jinan, China (Not_yet_recruiting)
• Jingzhou First People's Hospital — Jingzhou, China (Recruiting)
• Affiliated Hospital of Jining Medical University — Jining, China (Not_yet_recruiting)
• Yunnan Cancer Hospital — Kunming, China (Recruiting)
• Liuzhou People's Hospital — Liuzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, China (Not_yet_recruiting)
• Meizhou People's Hospital — Meizhou, China (Not_yet_recruiting)
• Mianyang Central Hospital — Mianyang, China (Not_yet_recruiting)
• Jiangxi Cancer Hospital — Nanchang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (Not_yet_recruiting)
• Nanchong Central Hospital — Nanchong, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, China (Not_yet_recruiting)
• Nanjing Drum-Tower Hospital — Nanjing, China (Not_yet_recruiting)
• Guangxi Medical University Cancer Hospital — Nanning, China (Not_yet_recruiting)
• Nanyang Central Hospital — Nanyang, China (Not_yet_recruiting)
• Qujing NO.1 Hospital — Qujing, China (Not_yet_recruiting)
• The Fourth Hospital of Hebei Medical University — Shijia Zhuang, China (Not_yet_recruiting)
• Taizhou Enze Medical Center (group) — Taizhou, China (Not_yet_recruiting)
• Weifang NO.2 People's Hospital — Weifang, China (Not_yet_recruiting)
• Weihai Municipal Hospital — Weihai, China (Not_yet_recruiting)
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China (Not_yet_recruiting)
• Zhongnan Hospital Of Wuhan University — Wuhan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, China (Not_yet_recruiting)
• Xiangyang Central Hospital — Xiangyang, China (Recruiting)
• Xuzhou Central Hospital — Xuzhou, China (Not_yet_recruiting)
• The Second People's Hospital Of Yibin — Yibin, China (Not_yet_recruiting)
• Yongzhou Central Hospital — Yongzhou, China (Not_yet_recruiting)
• Yuncheng City Center Hospital — Yuncheng, China (Not_yet_recruiting)
• Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou, China (Not_yet_recruiting)
• Zhoukou Central Hospital — Zhoukou, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Ying Cheng — Jilin Provincial Tumor Hospital
• Study coordinator: Jia Song

Conditions SCLC; Second-line