A Phase 2 Clinical Trial of TQB2102 for Injection in Locally Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Gene Abnormality to Evaluate the Efficacy and Safety

Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in locally advanced or metastatic non-small cell lung cancer with HER2 gene abnormality.

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

• Subjects voluntarily participate in this study and sign informed consent;

• Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;

• Patients with locally advanced, metastatic, or recurrent non-small cell lung cancer that is cytologically or histologically proven to be inoperable and cannot be treated with radical concurrent chemoradiotherapy;

• Previous standard treatments failed;

• At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);

• Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.

Locations
Other Locations
China
Beijing Cancer Hospital
NOT_YET_RECRUITING
Beijing
Jilin Cancer Hospital
NOT_YET_RECRUITING
Changchun
Hunan Provincial Tumor Hospital
NOT_YET_RECRUITING
Changsha
Sichuan Cancer Hospital
NOT_YET_RECRUITING
Chengdu
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Foshan First People's Hospital
NOT_YET_RECRUITING
Foshan
Fujian Cancer Hospital
RECRUITING
Fuzhou
First Affiliated Hospital of Gannan Medical University
NOT_YET_RECRUITING
Ganzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
Harbin Medical University cancer hospital
NOT_YET_RECRUITING
Harbin
Jiangmen Central Hospital
NOT_YET_RECRUITING
Jiangmen
Affiliated Cancer Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
Leshan People's Hospital
NOT_YET_RECRUITING
Leshan
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Jiangsu Provincial People's Hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
The Second People's Hospital of Shenzhen
NOT_YET_RECRUITING
Shenzhen
Tianjin Medical University Cancer Institute&Hpspital
NOT_YET_RECRUITING
Tianjin
Xinjiang Uygur Autonomous Region Cancer Hospital
NOT_YET_RECRUITING
Ürümqi
The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU
NOT_YET_RECRUITING
Wenzhou
Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
The Second Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Li Zhang, Doctor
Zhangli6@mail.sysu.edu.cn
020-87343458
Backup
Qiming Wang, Doctor
qimingwang1006@126.com
13783590691
Time Frame
Start Date: 2024-08-06
Estimated Completion Date: 2026-02
Participants
Target number of participants: 270
Treatments
Experimental: TQB2102 for injection
Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.
Experimental: TQB2102 for injection+Benmelstobart injection
TQB2102 for injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle; Benmelstobart injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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