RecruitingPhase 2NCT06496490

A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene Abnormality

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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Enrollment

270 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called TQB2102 in patients with advanced non-small cell lung cancer (NSCLC) whose tumors have a specific genetic change in the HER2 gene. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced, metastatic, or recurrent NSCLC that cannot be surgically removed - Your tumor has a confirmed HER2 gene mutation or amplification - You have already tried at least one prior cancer treatment - Your general health score (ECOG) is 0 or 1, and your estimated survival is at least 3 months **You may NOT be eligible if...** - You have never been treated for lung cancer before (first-line only trials may apply instead) - You have untreated brain metastases or serious heart conditions - You have received drugs that target HER2 previously (or other disqualifying prior treatments) - You are pregnant or unable to use contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2102 for injection

HER2 dual-antibody-drug Conjugate (ADC).

DRUGTQB2102 for injection combined with Benmelstobart injection

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).

Locations(25)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Foshan First People's Hospital

Foshan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

The Second Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Harbin Medical University cancer hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Leshan People's Hospital

Leshan, Sichuan, China

Xinjiang Uygur Autonomous Region Cancer Hospital

Ürümqi, Xinjiang, China

The 1th School of Medicine,School of Information and Engineering.The 1th Affiliated Hospital of WMU

Wenzhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tianjin Medical University Cancer Institute&Hpspital

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT06496490

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