It's a Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in sequential maintenance TQB2450 injection therapy in patients after sequential or concurrent chemoradiation for locally advanced non-small cell lung cancer. Incidence and severity of adverse events (AEs), the type of dose-limiting toxicity(ies) (DLT\[s\]) and Recommended phaseII dose(RP2D) were the Phase Ib primary endpoint. Overall response rate (ORR) was the Phase II primary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Incidence of adverse events (AEs)
All adverse medical events that occur after the subject receives the investigational drug evaluated according to the National Cancer Institute standard for common toxic reactions (NCI-CTC) V5.0.
Time frame: Baseline to 30 days after last administration.
Severity of adverse events (AEs)
All adverse medical events that occur after the subject receives the investigational drug evaluated according to the National Cancer Institute standard for common toxic reactions (NCI-CTC) V5.0.
Time frame: Baseline to 30 days after last administration.
Dose-limiting toxicity (DLT)
Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade IV hematological toxicity, neutropenia associated with fever.
Time frame: Up to 28 days.
Recommended phase II dose (RP2D)
The RP2D defined as the lower dose level to maximum tolerated dose based on the safety profile.
Time frame: Baseline to 30 days after last administration.
Overall response rate (ORR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the proportion of subjects whose tumors are evaluated as complete response (CR) and partial response (PR) by subcenter imaging evaluation. It is recorded from the first dose of the drug to disease progression or initiation of a new anticancer treatment.
Time frame: Baseline to the disease progression, up to two years.
Time to reach maximum plasma concentration (Tmax)
To characterize the pharmacokinetics of TQB3728 by assessment of time to reach maximum plasma concentration.
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Peak concentration (Cmax)
Cmax is the maximum plasma concentration of TQB3728 or metabolite(s).
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Terminal half-life (t1/2)
Pharmacokinetics parameters to evaluate the half life of TQB3728.
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Area under the plasma concentration-time curve from time zero to time t.
To characterize the pharmacokinetics of TQB3728 by assessment of area under the plasma concentration time curve from zero to specific time or infinity.
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Cmax,ss is the steady state maximum concentration of TQB3728.
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss)
Cmin,ss is the minimum plasma concentration of TQB3728.
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Disease control rate (DCR)
Percentage of subjects achieving CR and PR and stable disease (SD).
Time frame: Baseline to up to two years.
Duration of Response (DOR)
The period from the subjects first achieving CR or PR to disease progression.
Time frame: Baseline to up to two years.
Progression-free survival (PFS) at 12 months.
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Time frame: Up to 12 months.
Progression-free survival at 18 months.
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Time frame: Up to 18 months.
Progression-free survival.
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Time frame: Baseline to the disease progression, up to two years.
Overall survival (OS) at 12 months.
OS is defined as the time from the first administration to all-cause death.
Time frame: Up to 12 months.
Overall survival (OS) at 18 months.
OS is defined as the time from the first administration to all-cause death.
Time frame: Up to 18 months.
Overall survival (OS)
OS is defined as the time from the first administration to all-cause death.
Time frame: Baseline to the disease progression, up to two years.
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