This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.
Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation
The ECOG score is 0 or 1
The expected survival is ≥12 weeks
There are untreated or active central nervous system (CNS) tumor metastases
Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration
Systemic antitumor therapy was performed 4 weeks prior to study initiation
Prior treatment with antibody-conjugated drugs
Single group
SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316
DrugDrug: SHR-A1811 \& Pyrotinib SHR-A1811： intravenous Pyrotinib：oral Drug: SHR-A1811 \& SHR-1316 SHR-A1811： intravenous SHR-1316： intravenous
DLT(Phase I (dose exploration phase) main study endpoint)
AE(Phase I (dose exploration phase) main study endpoint)
Incidence and severity of serious adverse events (SAE)(Phase I (dose exploration phase) main study endpoint)
Objective response rate(The main end points of the second stage (efficacy expansion stage))
Toxin binding antibody to shr-a1811（Phase I secondary endpoint）
Total antibody to shr-a1811（Phase I secondary endpoint）
Plasma concentration of free toxin shr169265（Phase I secondary endpoint）
Plasma concentration of pyrroltinib（Phase I secondary endpoint）
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