This trial is a registrational Phase II/III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in combination with osimertinib in resectable EGFR-mutant non-small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Administration by intravenous infusion for a cycle of 3 weeks.
Oral administration for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Major Pathological Response (MPR)
MPR is defined as the presence of viable tumor tissue ≤10% in the surgical specimen at the time of tumor resection.
Time frame: Up to approximately 24 months
Pathologic complete response (pCR)
pCR is defined as the absence of any residual tumor (lesions) in the primary tumor upon surgical resection.
Time frame: Up to approximately 24 months
Event-Free Survival (EFS)
EFS is defined as the time from randomization to the occurrence of any of the following events, whichever occurs first.
Time frame: Up to approximately 24 months
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Time frame: Up to approximately 24 months
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.
Time frame: Up to approximately 24 months
Anti-drug antibody (ADA)
Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.
Time frame: Up to approximately 24 months
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Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.