Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06616532

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

Led by Biotheus Inc. · Updated on 2024-12-19

404

Participants Needed

45

Research Sites

214 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily agree to participate and able to complete all study procedures
  • Age 18 to 75 years
  • Histologically or cytologically confirmed small cell lung cancer
  • Advanced small cell lung cancer progressed or relapsed after first-line platinum chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors)
  • Adequate organ function
  • Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
  • Life expectancy of at least 12 weeks
  • At least one measurable tumor lesion based on RECIST v1.1
Not Eligible

You will not qualify if you...

  • History of severe allergic disease, severe drug allergy, or allergy to any study drug components
  • Previous treatment with Paclitaxel, Topotecan, or anti-vascular endothelial growth factor (VEGF) drugs
  • Severe superior vena cava syndrome or spinal cord compression currently present
  • Adverse events from prior anti-tumor therapies not resolved to Grade 1 or lower
  • Significant clotting disorders or bleeding risks
  • Severe, uncontrollable, or active cardiovascular disease within last 6 months
  • Uncontrollable pleural, pericardial, or peritoneal effusions currently present
  • HIV infection or AIDS
  • History of allogeneic hematopoietic stem cell or organ transplantation
  • History of alcohol, psychotropic substance, or drug abuse
  • Pregnant or breastfeeding women
  • Other conditions deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 45 locations

1

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Not Yet Recruiting

2

Jilin Cancer Hospital

Changchun, Jilin, China

Actively Recruiting

3

The First Affiliated Hospital Of Ningbo University

Ningbo, Zhejiang, China

Not Yet Recruiting

4

Binzhou Medical University Hospital

Binzhou, China

Not Yet Recruiting

5

Hunan Cancer Hospital

Changsha, China

Not Yet Recruiting

6

Sichuan Cancer Hospital

Chengdu, China

Actively Recruiting

7

First People's Hospital of Chenzhou

Chenzhou, China

Not Yet Recruiting

8

The First Affiliated Hospital of Army Medical University

Chongqing, China

Not Yet Recruiting

9

The Second Hospital of Dalian Medical University

Dalian, China

Not Yet Recruiting

10

The First People's Hospital of Foshan

Foshan, China

Not Yet Recruiting

11

Fujian Cancer Hospital

Fuzhou, China

Actively Recruiting

12

The Affiliated Hospital Of Guilin Medical University

Guilin, China

Not Yet Recruiting

13

Zhejiang Cancer Hospital

Hangzhou, China

Not Yet Recruiting

14

Harbin Medical University Cancer Hospital

Harbin, China

Not Yet Recruiting

15

Anhui Province Hospital

Hefei, China

Not Yet Recruiting

16

Shandong Cancer Institute

Jinan, China

Not Yet Recruiting

17

Jingzhou First People's Hospital

Jingzhou, China

Actively Recruiting

18

Affiliated Hospital of Jining Medical University

Jining, China

Not Yet Recruiting

19

Yunnan Cancer Hospital

Kunming, China

Actively Recruiting

20

Liuzhou People's Hospital

Liuzhou, China

Not Yet Recruiting

21

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, China

Not Yet Recruiting

22

Meizhou People's Hospital

Meizhou, China

Not Yet Recruiting

23

Mianyang Central Hospital

Mianyang, China

Not Yet Recruiting

24

Jiangxi Cancer Hospital

Nanchang, China

Not Yet Recruiting

25

The First Affiliated Hospital of Nanchang University

Nanchang, China

Not Yet Recruiting

26

Nanchong Central Hospital

Nanchong, China

Not Yet Recruiting

27

Jiangsu Province Hospital

Nanjing, China

Not Yet Recruiting

28

Nanjing Drum-Tower Hospital

Nanjing, China

Not Yet Recruiting

29

Guangxi Medical University Cancer Hospital

Nanning, China

Not Yet Recruiting

30

Nanyang Central Hospital

Nanyang, China

Not Yet Recruiting

31

Qujing NO.1 Hospital

Qujing, China

Not Yet Recruiting

32

The Fourth Hospital of Hebei Medical University

Shijia Zhuang, China

Not Yet Recruiting

33

Taizhou Enze Medical Center (group)

Taizhou, China

Not Yet Recruiting

34

Weifang NO.2 People's Hospital

Weifang, China

Not Yet Recruiting

35

Weihai Municipal Hospital

Weihai, China

Not Yet Recruiting

36

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Not Yet Recruiting

37

Zhongnan Hospital Of Wuhan University

Wuhan, China

Not Yet Recruiting

38

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Not Yet Recruiting

39

Xiangyang Central Hospital

Xiangyang, China

Actively Recruiting

40

Xuzhou Central Hospital

Xuzhou, China

Not Yet Recruiting

41

The Second People's Hospital Of Yibin

Yibin, China

Not Yet Recruiting

42

Yongzhou Central Hospital

Yongzhou, China

Not Yet Recruiting

43

Yuncheng City Center Hospital

Yuncheng, China

Not Yet Recruiting

44

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, China

Not Yet Recruiting

45

Zhoukou Central Hospital

Zhoukou, China

Not Yet Recruiting

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Research Team

J

Jia Song

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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