This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.
Voluntarily sign the informed consent form (ICF);
ECOG 0-1;
Survival duration more than 3 months;
Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and cannot receive curative concurrent/sequential chemoradiotherapy;
Histologically or cytologically confirmed presence of small cell carcinoma components;
Prior treatment with docetaxel;
Symptomatic central nervous system (CNS) metastases;
Received the last dose of prior systemic anti-tumor therapy within 4 weeks before the first dose of study drug;
Single group
SCTB41
DrugSCTB41 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle
docetaxel
Drugdocetaxel is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle
Frequency of adverse events (AEs)
To investigate the safety characteristics.
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.
Progression-free survival (PFS)
The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.
Overall survival (OS)
Overall survival is defined as the time from the start of treatment until death due to any cause.
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This trial is not recruiting at the moment. You can still explore other options:
