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

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 informedconsent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survivaltime ≥3 months;

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

• Previous standard treatments failed；

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

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

• Adverse effects due to any prior treatment have not been restored toCommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hairloss);

• Major surgical treatment, incision biopsy, or significant traumatic injury werereceived 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-relatedpneumonia treated with steroids in the past, or active non-infectious pneumonia withinterstitial changes such as interstitial lung disease, radiation pneumonia, andimmune-related pneumonia in the screening period, active pulmonary tuberculosis,pneumoconiosis, or other types of pneumonia ≥ grade 2, or severe impairment of lungfunction 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 toabstain 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 patentdrugs with anti-tumor indications clearly stated in the National MedicalProductsAdministration approved drug instructions were treated;

• Local focal palliative radiotherapy was received within 2 weeks before the firstdose;

• Patients with serous effusion requiring repeated drainage to relieve clinicalsymptoms or who have received serous effusion drainage for therapeutic purposeswithin 2 weeks prior to treatment;

• There is symptomatic or progressive exacerbation of central nervous systemmetastatic or cancerous meningitis with diffuse spread. Subjects with a history ofbrain metastases may be considered for inclusion if they are clinically stable;

• Severe bone injury caused by tumor bone metastasis, including pathological fracturesand spinal cord compression that occurred within 6 months or are likely to occur inthe near future;

• Pain associated with uncontrolled bone metastases;

• Allergic to humanized monoclonal antibody products;

• Allergic to any investigational drug or to any ingredient or excipient in the drug;

• Persons who have received live attenuated vaccine within 4 weeks prior to treatment;

• Subjects who, in the investigator's judgment, have concomitant diseases thatseriously endanger the safety of subjects or interfere with the completion of thestudy, or who are deemed unsuitable for enrollment for other reasons.