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;
Parallel
TQB2102 for injection
DrugHER2 dual-antibody-drug Conjugate (ADC).
TQB2102 for injection combined with Benmelstobart injection
DrugTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC); Benmelstobart injection is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1).
Overall Response Rate (ORR)
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).
Duration Of Remission (DOR)
DOR defined as the time when the participants first achieved complete or partial remission to disease progression.
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.
Overall Survival (OS)
OS defined as the time from the first injection to death from any cause.
Frequency of adverse event (AE)
The occurrence of all adverse medical events after the first injection.
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