This trial is a registrational Phase II/III randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in combination with PD-1/VEGF bispecific antibody in first-line patients with locally advanced or metastatic squamous non-small cell lung cancer.
The entire study consists of two stages, Phase II and Phase III, both of which are randomized, open-label studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Phase II: Investigator-assessed Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Time frame: Up to approximately 24 months
Phase II: Investigator-assessed Progression-free Survival (PFS)
Investigator-assessed progression-free survival (PFS) per RECIST v1.1 is defined as the time from treatment initiation until the first documented disease progression according to RECIST v1.1 criteria, or death from any cause, whichever occurs first, as determined by the local treating investigator.
Time frame: Up to approximately 24 months
Phase III: BICR-assessed Progression-free Survival (PFS)
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
Time frame: Up to approximately 24 months
Phase II/III: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
Phase II/III: Progression-free Survival (PFS)
Progression-free Survival (PFS) is defined as the time from randomization or start of treatment until the first documented evidence of disease progression or death from any cause, whichever occurs first.
Time frame: Up to approximately 24 months
Phase II/III: Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).
Time frame: Up to approximately 24 months
Phase II/III: Disease Control Rate (DCR)
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.
Time frame: Up to approximately 24 months
Phase II/III: Duration of Response (DOR)
Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.
Time frame: Up to approximately 24 months
Phase II/III: Cmax
Cmax is defined as the maximum observed drug concentration in plasma after administration.
Time frame: Up to approximately 24 months
Phase II/III: Tmax
Tmax is defined as the time required to reach the maximum drug concentration in plasma following drug administration.
Time frame: Up to approximately 24 months
Phase II/III: T1/2
T1/2 is defined as the time required for the plasma concentration of a drug to decrease by 50% during the elimination phase.
Time frame: Up to approximately 24 months
Phase II/III: AUC0-t
AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.
Time frame: Up to approximately 24 months
Phase II/III: CL (Clearance)
Clearance (CL) is the volume of plasma from which a drug is completely removed per unit time.
Time frame: Up to approximately 24 months
Phase II/III: Ctrough
Ctrough is defined as the lowest serum concentration prior to the next dose will be administered.
Time frame: Up to approximately 24 months
Phase II/III: Anti-drug Antibody (ADA)
Anti-drug Antibody (ADA) refers to endogenous antibodies generated in subjects that specifically bind to the investigational drug.
Time frame: Up to approximately 24 months
Phase II/III: Neutralizing Antibody(NAb)
Frequency of anti-BL-B01D1 neutralizing antibodies will be investigated.
Time frame: Up to approximately 24 months
Phase II: Drug-Drug Interaction (DDI)
Drug-Drug Interaction (DDI) is a situation in which one drug affects the activity, metabolism, or toxicity of another drug when they are administered concurrently (or within a short time interval).
Time frame: Up to approximately 24 months
Phase III: 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
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