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

Status: Recruiting
Location: See all (45) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Binzhou Medical University Hospital
NOT_YET_RECRUITING
Binzhou
Jilin Cancer Hospital
RECRUITING
Changchun
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Sichuan Cancer Hospital
RECRUITING
Chengdu
First People's Hospital of Chenzhou
NOT_YET_RECRUITING
Chenzhou
The First Affiliated Hospital of Army Medical University
NOT_YET_RECRUITING
Chongqing
The Second Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
The First People's Hospital of Foshan
NOT_YET_RECRUITING
Foshan
Fujian Cancer Hospital
RECRUITING
Fuzhou
The Affiliated Hospital Of Guilin Medical University
NOT_YET_RECRUITING
Guilin
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Anhui Province Hospital
NOT_YET_RECRUITING
Hefei
Shandong Cancer Institute
NOT_YET_RECRUITING
Jinan
Jingzhou First People's Hospital
RECRUITING
Jingzhou
Affiliated Hospital of Jining Medical University
NOT_YET_RECRUITING
Jining
Yunnan Cancer Hospital
RECRUITING
Kunming
Liuzhou People's Hospital
NOT_YET_RECRUITING
Liuzhou
The First Affiliated Hospital of Henan University of Science & Technology
NOT_YET_RECRUITING
Luoyang
Meizhou People's Hospital
NOT_YET_RECRUITING
Meizhou
Mianyang Central Hospital
NOT_YET_RECRUITING
Mianyang
Jiangxi Cancer Hospital
NOT_YET_RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Nanchong Central Hospital
NOT_YET_RECRUITING
Nanchong
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Nanjing Drum-Tower Hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Affiliated Hospital of Nantong University
NOT_YET_RECRUITING
Nantong
Nanyang Central Hospital
NOT_YET_RECRUITING
Nanyang
The First Affiliated Hospital Of Ningbo University
NOT_YET_RECRUITING
Ningbo
Qujing NO.1 Hospital
NOT_YET_RECRUITING
Qujing
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijia Zhuang
Taizhou Enze Medical Center (group)
NOT_YET_RECRUITING
Taizhou
Weifang NO.2 People's Hospital
NOT_YET_RECRUITING
Weifang
Weihai Municipal Hospital
NOT_YET_RECRUITING
Weihai
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Zhongnan Hospital Of Wuhan University
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Xiangyang Central Hospital
RECRUITING
Xiangyang
Xuzhou Central Hospital
NOT_YET_RECRUITING
Xuzhou
The Second People's Hospital Of Yibin
NOT_YET_RECRUITING
Yibin
Yongzhou Central Hospital
NOT_YET_RECRUITING
Yongzhou
Yuncheng City Center Hospital
NOT_YET_RECRUITING
Yuncheng
Zhangzhou Municipal Hospital of Fujian Province
NOT_YET_RECRUITING
Zhangzhou
Zhoukou Central Hospital
NOT_YET_RECRUITING
Zhoukou
Contact Information
Primary
Jia Song
song.j@biotheus.com
+86 15921737659
Time Frame
Start Date: 2024-11-13
Estimated Completion Date: 2028-12-25
Participants
Target number of participants: 404
Treatments
Experimental: PM8002+Paclitaxel
Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion.
Active_comparator: Chemotherapy
Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W.
Sponsors
Leads: Biotheus Inc.

This content was sourced from clinicaltrials.gov

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