This study was designed to compare the efficacy and safety of IBB0979 in combination with topotecan versus topotecan in subjects with relapsed small cell lung cancer (SCLC).
Aged ≥18 and ≤75 years, male or female.
Histologically confirmed SCLC.
Relapsed small cell lung cancer (limited-stage, extensive-stage) that has failed or progressed after first-line or second-line systemic therapy.
At least one measurable lesion according to RECIST version 1.1.
Combined SCLC, any previous diagnosis of transformed SCLC or SCLC that has transformed to NSCLC.
Known hypersensitivity (≥ Grade 3) to recombinant proteins or any excipient contained in the drug or vehicle formulation for IBB0979.
History of anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy within 4 weeks) prior to the initiation of investigational product administration.
History of any un-marketed investigational product or therapy within 4 weeks prior to the initiation of investigational product administration.
SUNHO（China）BioPharmaceutical CO., Ltd.
Lead sponsor
Zhengzhou University
Collaborator