A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality
NCT Number: NCT06496490
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-Small Cell Lung Cancer
Interventions: DRUG: TQB2102 for injection
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-06
Completion Date: 2026-02
Locations: Fujian Cancer Hospital, Fuzhou, Fujian, 350014, China|Foshan First People's Hospital, Foshan, Guangdong, 528000, China|Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, China|Jiangmen Central Hospital, Jiangmen, Guangdong, 529000, China|The Second People's Hospital of Shenzhen, Shenzhen, Guangdong, 518035, China|Harbin Medical University cancer hospital, Harbin, Heilongjiang, 150081, China|Henan Cancer Hospital, Zhengzhou, Henan, 450000, China|Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, 430000, China|Hunan Provincial Tumor Hospital, Changsha, Hunan, 410031, China|Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, 210000, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, 330006, China|Jilin Cancer Hospital, Changchun, Jilin, 130012, China|The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710000, China|Affiliated Cancer Hospital of Shandong First Medical University, Jinan, Shandong, 250117, China|Xinjiang Uygur Autonomous Region Cancer Hospital, Ürümqi, Xinjiang, 830001, China|The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU, Wenzhou, Zhejiang, 325015, China|Beijing Cancer Hospital, Beijing, 100142, China|Fudan University Shanghai Cancer Center, Shanghai, 200032, China|Tianjin Medical University Cancer Institute&Hpspital, Tianjin, 300181, China

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.

Primary Outcome Measures: Overall Response Rate (ORR), ORR defined as percentage of participants achieving complete response (CR) and partial response (PR)., Baseline up to 8 months
Secondary Outcome Measures: Duration Of Remission (DOR), DOR defined as the time when the participants first achieved complete or partial remission to disease progression., 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., Baseline up to 8 months|Overall Survival (OS), OS defined as the time from the first injection to death from any cause., Baseline up to 18 months|Frequency of adverse event (AE), The occurrence of all adverse medical events after the first injection., 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., 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), 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).