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

RECRUITINGPHASE2

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

NCT06496490•Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•Has diagnosed and/or treated additional malignancy within 3 years prior to take medication;
•Adverse effects due to any prior treatment have not been restored to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
•Major surgical treatment, incision biopsy, or significant traumatic injury were received within 28 days prior to study treatment,and minor traumatic surgery (biopsy, bronchoscopy, and chest drainage) within 7 days;
•Long-term unhealed wounds or fractures;
•History of interstitial lung disease, radiation pneumonia, and immune-related pneumonia treated with steroids in the past, or active non-infectious pneumonia with interstitial changes such as interstitial lung disease, radiation pneumonia, and immune-related pneumonia in the screening period, active pulmonary tuberculosis, pneumoconiosis, or other types of pneumonia ≥ grade 2, or severe impairment of lung function confirmed by pulmonary function examination;
•Arterial/deep vein thrombosis events occurred within 6 months prior to treatment, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism;
•Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
•Patients with any severe and/or uncontrolled disease;
•Any anticancer therapy or any other investigational drug treatment within 28 days or 5 half-lives prior to the first dosing of this study;
•Within 1 week prior to the first administration of this study, the Chinese patent drugs with anti-tumor indications clearly stated in the National MedicalProducts Administration approved drug instructions were treated;
+9 more criteria

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

Key Dates

Start Date

August 6, 2024

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

November 20, 2025

Enrollment

270

ESTIMATED participants

Conditions

Non-Small Cell Lung Cancer

Interventions

TQB2102 for injection

DRUG

TQB2102 for injection combined with Benmelstobart injection

DRUG

Contacts

Li Zhang, Doctor

CONTACT

020-87343458 Zhangli6@mail.sysu.edu.cn

Qiming Wang, Doctor

CONTACT

13783590691 qimingwang1006@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)