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

Last updated: December 18, 2024
Sponsor: Biotheus Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Treatment

Topotecan

PM8002

Paclitaxel

Clinical Study ID

NCT06616532
PM8002-C014C-SCLC-R
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary participation in this clinical study; full understanding of the study andvoluntary signing the informed consent form; willing to follow and abling tocomplete 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-containingchemotherapy (extensive-stage patients must have received immune checkpointinhibitors);

  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

Exclusion Criteria:

  1. History of severe allergic disease, severe drug allergy or have known allergy to anycomponent of the study drugs;

  2. Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growthfactor (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 andgraded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned toGrade 1 or below;

  5. Evidence of significant clotting disorder or other significant bleeding risk;

  6. History of severe, uncontrollable, or active cardiovascular diseases within 6months;

  7. Current presence of uncontrollable pleural, pericardial, and peritoneal effusions;

  8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiencysyndrome;

  9. History of allogeneic hematopoietic stem cell transplantation or allogeneic organtransplantation;

  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.

Study Design

Total Participants: 404
Treatment Group(s): 3
Primary Treatment: Topotecan
Phase: 3
Study Start date:
November 13, 2024
Estimated Completion Date:
December 25, 2028

Study Description

This multicenter, randomized, open-label phase III study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel versus Investigator's Choice (Topotecan or Paclitaxel) as second-line treatment for subjects with SCLC.

Connect with a study center

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, Jilin
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Ningbo University

    Ningbo, Zhejiang
    China

    Site Not Available

  • Binzhou Medical University Hospital

    Binzhou,
    China

    Site Not Available

  • Jilin Provincial Tumor Hospital

    Changchun,
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha,
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu,
    China

    Active - Recruiting

  • First People's Hospital of Chenzhou

    Chenzhou,
    China

    Site Not Available

  • The First Affiliated Hospital of Army Medical University

    Chongqing,
    China

    Site Not Available

  • The Second Hospital of Dalian Medical University

    Dalian,
    China

    Site Not Available

  • The First People's Hospital of Foshan

    Foshan,
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou,
    China

    Active - Recruiting

  • The Affiliated Hospital Of Guilin Medical University

    Guilin,
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou,
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin,
    China

    Site Not Available

  • Anhui Province Hospital

    Hefei,
    China

    Site Not Available

  • Shandong Cancer Institute

    Jinan,
    China

    Site Not Available

  • Jingzhou First People's Hospital

    Jingzhou,
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining,
    China

    Site Not Available

  • Yunnan Cancer Hospital

    Kunming,
    China

    Active - Recruiting

  • Liuzhou People's Hospital

    Liuzhou,
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang,
    China

    Site Not Available

  • Meizhou People's Hospital

    Meizhou,
    China

    Site Not Available

  • Mianyang Central Hospital

    Mianyang,
    China

    Site Not Available

  • Jiangxi Cancer Hospital

    Nanchang,
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Site Not Available

  • Nanchong Central Hospital

    Nanchong,
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing,
    China

    Site Not Available

  • Nanjing Drum-Tower Hospital

    Nanjing,
    China

    Site Not Available

  • Guangxi Medical University Cancer Hospital

    Nanning,
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang,
    China

    Site Not Available

  • Qujing NO.1 Hospital

    Qujing,
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijia Zhuang,
    China

    Site Not Available

  • Taizhou Enze Medical Center (group)

    Taizhou,
    China

    Site Not Available

  • Weifang NO.2 People's Hospital

    Weifang,
    China

    Site Not Available

  • Weihai Municipal Hospital

    Weihai,
    China

    Site Not Available

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

    Wuhan,
    China

    Site Not Available

  • Zhongnan Hospital Of Wuhan University

    Wuhan,
    China

    Site Not Available

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an,
    China

    Site Not Available

  • Xiangyang Central Hospital

    Xiangyang,
    China

    Active - Recruiting

  • Xuzhou Central Hospital

    Xuzhou,
    China

    Site Not Available

  • The Second People's Hospital Of Yibin

    Yibin,
    China

    Site Not Available

  • Yongzhou Central Hospital

    Yongzhou,
    China

    Site Not Available

  • Yuncheng City Center Hospital

    Yuncheng,
    China

    Site Not Available

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou,
    China

    Site Not Available

  • Zhoukou Central Hospital

    Zhoukou,
    China

    Site Not Available

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