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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
270
HER2 dual-antibody-drug Conjugate (ADC).
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC); Benmelstobart injection is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).
Fujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGFoshan First People's Hospital
Foshan, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGJiangmen Central Hospital
Jiangmen, Guangdong, China
Overall Response Rate (ORR)
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: Baseline up to 8 months
Duration Of Remission (DOR)
DOR defined as the time when the participants first achieved complete or partial remission to disease progression.
Time frame: Baseline up to 8 months
Progression-Free Survival (PFS)
PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.
Time frame: Baseline up to 8 months
Overall Survival (OS)
OS defined as the time from the first injection to death from any cause.
Time frame: Baseline up to 18 months
Frequency of adverse event (AE)
The occurrence of all adverse medical events after the first injection.
Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Severity of adverse event (AE)
The severity of all adverse medical events after the first injection.
Time frame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Anti-drug antibody (ADA)
Incidence of anti-drug antibody (ADA)
Time frame: Before infusion on Cycle1 Day1, Cycle2 Day1, Cycle 4 Day1, Cycle7 Day1, Cycle12 Day1 (each cycle is 21 days), 90 days after the end of the last infusion (each cycle is 21 days).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
NOT_YET_RECRUITINGHarbin Medical University cancer hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGTongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITING...and 15 more locations