PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in 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
1 other identifier
interventional
404
1 country
45
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2024
Typical duration for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedStudy Start
First participant enrolled
November 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 25, 2028
May 22, 2026
April 1, 2026
2.2 years
September 23, 2024
May 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.
Up to approximately 32 months from first patient in
Secondary Outcomes (11)
Progression-Free Survival (PFS) assessed by evaluated by investigator
Up to approximately 32 months from first patient in
Objective response rate (ORR) evaluated by investigator
Up to approximately 32 months from first patient in
Disease control rate (DCR)
Up to approximately 32 months from first patient in
Time to response (TTR)
Up to approximately 32 months from first patient in
Duration of response (DOR)
Up to approximately 32 months from first patient in
- +6 more secondary outcomes
Study Arms (2)
PM8002+Paclitaxel
EXPERIMENTALSubjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.
Chemotherapy
ACTIVE COMPARATORSubjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- Age ≥18 years but ≤75 years;
- Histologically or cytologically confirmed SCLC;
- Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors);
- Having adequate organ functions;
- The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
- Life expectancy of 12 weeks or more;
- Having at least one measurable tumor lesion according to RECIST v1.1;
You may not qualify if:
- History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
- Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs;
- Current presence of severe superior vena cava syndrome and spinal cord compression;
- 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;
- Evidence of significant clotting disorder or other significant bleeding risk;
- History of severe, uncontrollable, or active cardiovascular diseases within 6 months;
- Current presence of uncontrollable pleural, pericardial, and peritoneal effusions;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
- History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
- History of alcohol abuse, psychotropic substance abuse or drug abuse;
- Pregnant or lactating women;
- Other conditions considered unsuitable for this study by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotheus Inc.lead
Study Sites (45)
Binzhou Medical University Hospital
Binzhou, China
Jilin Cancer Hospital
Changchun, China
Hunan Cancer Hospital
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
First People's Hospital of Chenzhou
Chenzhou, China
The First Affiliated Hospital of Army Medical University
Chongqing, China
The Second Hospital of Dalian Medical University
Dalian, China
The First People's Hospital of Foshan
Foshan, China
Fujian Cancer Hospital
Fuzhou, China
The Affiliated Hospital Of Guilin Medical University
Guilin, China
Zhejiang Cancer Hospital
Hangzhou, China
Harbin Medical University Cancer Hospital
Harbin, China
Anhui Province Hospital
Hefei, China
Shandong Cancer Institute
Jinan, China
Jingzhou First People's Hospital
Jingzhou, China
Affiliated Hospital of Jining Medical University
Jining, China
Yunnan Cancer Hospital
Kunming, China
Liuzhou People's Hospital
Liuzhou, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China
Meizhou People's Hospital
Meizhou, China
Mianyang Central Hospital
Mianyang, China
Jiangxi Cancer Hospital
Nanchang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Nanchong Central Hospital
Nanchong, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum-Tower Hospital
Nanjing, China
Guangxi Medical University Cancer Hospital
Nanning, China
Affiliated Hospital of Nantong University
Nantong, China
Nanyang Central Hospital
Nanyang, China
The First Affiliated Hospital Of Ningbo University
Ningbo, China
Qujing NO.1 Hospital
Qujing, China
The Fourth Hospital of Hebei Medical University
Shijia Zhuang, China
Taizhou Enze Medical Center (group)
Taizhou, China
Weifang NO.2 People's Hospital
Weifang, China
Weihai Municipal Hospital
Weihai, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Zhongnan Hospital Of Wuhan University
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xiangyang Central Hospital
Xiangyang, China
Xuzhou Central Hospital
Xuzhou, China
The Second People's Hospital Of Yibin
Yibin, China
Yongzhou Central Hospital
Yongzhou, China
Yuncheng City Center Hospital
Yuncheng, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, China
Zhoukou Central Hospital
Zhoukou, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caicun Zhou
Shanghai East Hospital
- PRINCIPAL INVESTIGATOR
Haifeng Liu
Jilin Provincial Tumor Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2024
First Posted
September 27, 2024
Study Start
November 13, 2024
Primary Completion (Estimated)
January 25, 2027
Study Completion (Estimated)
December 25, 2028
Last Updated
May 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After the trial completed.
- Access Criteria
- NCI is committed to sharing data in accordance with NIH policy.
The data will be published or presented for publications (poster, abstract,articles or papers) or any presentations.