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.
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；
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;