The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with Adebrelimab with or without other Antitumor Therapy in Advanced or Metastatic Non-small cell lung Cancer.
To explore the reasonable dosage of SHR-A2102 for Advanced or Metastatic Non-small cell lung Cancer
Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements.
The age of signing the informed consent is 18 -70 years, regardless of gender.
Provide archived or fresh tumor tissue for vendor test.
At least one measurable lesion according to RECIST v1.1 criteria.
Active or symptomatic brain metastases.
With the exception of patients diagnosed with any other malignancy, except those who have achieved complete remission at least 5 years prior to screening and have ended adjuvant therapy, can be treated locally and have a clear medical record of cure, such as basal cell or squamous cell carcinoma of the skin, superficial bladder cancer in situ, carcinoma in situ of the cervix, breast ductal carcinoma in situ, and papillary carcinoma of the thyroid.
Uncontrollable moderate to large amounts of pleural effusion, peritoneal effusion or pericardial effusion.
Patients with uncontrolled tumor-related pain .
Single group
SHR-A2102 for Injection
DrugDrug: SHR-A2102 for injection.
Adebrelimab Injection
DrugAdebrelimab injection.
Cisplatin injection
DrugCisplatin injection.
Carboplatin injection
DrugCarboplatin injection.
Bevacizumab Injection
DrugBevacizumab injection.
RP2D
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in Phase IB stages；
Incidence and severity of AE(DLT)
According to NCI-CTCAE v5.0 evaluation criteria from Day 1 to 90 days after last dose；
ORR
efficacy was assessed every 6 weeks within 48 weeks and every 9 weeks after 48 weeks s as determined by RECIST1.1
DCR
Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
DOR
Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
PFS(Investigator evaluation)
Since C1D1 every 6 weeks within 48 weeks and every 9 weeks after 48 weeks, and the proportion of subjects whose best response was PR or CR or SD as determined by RECIST1.1；
OS(Investigator evaluation)
Since C1D1 and death from any cause；
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