This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.
Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) NSCLC that is not amenable to radical surgery or radical radiochemotherapy, or Metastatic or recurrent NSCLC.
Subjects with unresectable locally advanced or metastatic or recurrent NSCLC who have failed first-line treatment with PD-1/PD-L1 inhibitors combined with platinum-based doublet chemotherapy (excluding docetaxel); or who have failed sequential first- and second-line treatment with PD-1/PD-L1 inhibitors followed by platinum-based doublet chemotherapy (excluding docetaxel).
Subjects must have at least one measurable lesion according to RECIST v1.1.
Histopathologically or cytopathologically confirmed to have combined neuroendocrine component.
Sensitivity mutation of EGFR or ALK fusion.
Tumor encircles important blood vessels or has obvious necrosis and air space, and the investigator considers that it may cause hemorrhage risk.
Parallel
JS207 injection +docetaxel
DrugPatients receive JS207 10mg/kg or other dosage and docetaxel 75mg/m2, q3w.
JS207 injection +JS004 injection
DrugPatients receive JS207 10mg/kg or other dosage and JS004 200mg, q3w.
JS207 injection
DrugPatients receive JS207 10mg/kg or other dosage.
Objective response rate (ORR)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)
Disease control rate (DCR)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)
Duration of response (DOR)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)
Progression-free survival (PFS)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)
Overall survival (OS)
To evaluate overall survival (OS)
the trough concentrations (PK)
to characterize the tough concentration of JS207\&JS004
Neutralizing antibody(Nab)
to characterize the neutralizing antibody of JS207\&JS004
Antidrug antibodies (ADA)
to characterize antidrug antibodies of JS207\&JS004
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