This is a multicenter, randomized, open-label Phase II/III clinical study, aiming to evaluate the efficacy and safety of LB1410 in combination with lenvatinib (whether in combination with LB4330)versus the chemotherapy regimen selected by the investigators for patients with advanced recurrent/metastatic cervical cancer.
This study is an open-label, multicenter Phase II/III clinical trial in advanced/metastatic cervical cancer to evaluate the antitumor efficacy, safety, tolerability, pharmacokinetics (PK), and biomarkers of LB1410 in combination with lenvatinib, with or without LB4330.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
LB1410 (IV, Q2W for up to 2 years)
LB4330 (IV, Q2W for 4 cycles)
lenvatinib (oral, once daily for up to 2 years)
Fudan University Shanghai Cancer Center
Shanghai, China
Objective Response Rate (ORR) assessed by an Independent Radiology Review Committee (IRRC)
defined as the percentage of patients with a best overall response of Complete Response or Partial Response per RECIST 1.1.
Time frame: Approximately 24 months
Duration of Response (DOR) assessed by an Independent Radiology Review Committee (IRRC)
defined as the time from the first documented response (CR or PR) to the first documented disease progression or death due to underlying cancer per RECIST 1.1.
Time frame: Approximately 24 months
Objective Response Rate (ORR) assessed by the investigator
defined as the percentage of patients with a best overall response of Complete Response or Partial Response per RECIST 1.1.
Time frame: Approximately 24 months
Duration of Response (DOR) assessed by the investigator
defined as the time from the first documented response (CR or PR) to the first documented disease progression or death due to underlying cancer per RECIST 1.1.
Time frame: Approximately 24 months
Disease Control Rate (DCR)
defined as the percentage of evaluable patients achieving a best overall response of complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1 assessed by both the investigator and an Independent Radiology Review Committee (IRRC).
Time frame: Approximately 24 months
Progression-Free Survival (PFS)
defined as the time from the first dose to the first documented disease progression per RECIST 1.1 or death due to any cause (whichever occurred first) assessed by both the investigator and an IRRC.
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Time frame: Approximately 24 months
Overall Survival (OS)
Overall Survival is defined as the time from the date of first study treatment to the date of death from any cause or the date of censoring.
Time frame: Until participant death/end of study,approximately 24 months
Safety and tolerability (Adverse Event reported per NCI-CTCAE v5.0)
Incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events reported per NCI-CTCAE v5.0
Time frame: From the first dose administration to 30 days after the last dose
ADA Antibody Positivity Rate of LB1410
ADA Antibody Positivity Rate of LB1410
Time frame: From the first dose administration to 30 days after the last dose
Pharmacokinetic (PK) parameters of LB1410-Maximum (peak) Plasma Concentration(Cmax)
The highest concentration a drug reaches in the bloodstream after a single dose.
Time frame: From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days)
Pharmacokinetic (PK) parameters of LB1410-Trough Concentration(Ctrough)
The minimum drug concentration at steady state, measured just before the next dose is administered.
Time frame: From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days)
Pharmacokinetic (PK) parameters of LB1410-Area Under the Curve at Steady State(AUCss)
The total area under the plasma concentration-time curve over one dosing interval at steady state, representing total drug exposure.
Time frame: From the first dose administration to Cycle 16 Day 1 (each cycle is 28 days)