This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
246
SCTB14 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle.
Pembrolizumab is administered at a fixed dose of 200 mg by intravenous infusion on Day 1 of each 3-week cycle.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGProgression-Free Survival (PFS) Assessed by Blinded Independent Central Review
Time from randomization to first documented progression or death (whichever occurs first).
Time frame: Up to approximately 1.5 years
overall survival
The time from the date of randomization to the date of death from any cause.
Time frame: Up to approximately 5 years
Progression-Free Survival (PFS) as Assessed by Investigator
Time from randomization to first documented progression or death (whichever occurs first).
Time frame: Up to approximately 1.5 years
Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Central Review
The proportion of subjects with a best overall confirmed response of Complete Response (CR) or Partial Response (PR)
Time frame: Up to approximately 1.5 years
Disease Control Rate (DCR) Assessed by Blinded Independent Central Review
The proportion of patients with a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Time frame: Up to approximately 1.5 years
Duration of Response (DOR)Assessed by Blinded Independent Central Review
The time from the first documented objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the first documented disease progression or death from any cause, whichever occurs first.
Time frame: Up to approximately 1.5 years
Time to Response (TTR)
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Time from the date of randomization to the first documented objective response (Complete Response \[CR\] or Partial Response \[PR\]
Time frame: Up to approximately 1.5 years
Treatment-Emergent Adverse Event(TEAE)
Any adverse event that occurs or worsens in severity after the initiation of study drug administration
Time frame: The first dose of study drug until 30 days (±7 days) after the last dose
Serious adverse events (SAEs)
An adverse medical event occurring after a subject receives the investigational drug that results in any of the following outcomes: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Time frame: From the first dose of study druguntil 60 days after the last dose.
immune-related adverse events (irAEs)
All grades of adverse drug reactions (ADRs) that occur after a subject receives the investigational drug and are assessed as having a causal relationship to an immune-mediated mechanism.
Time frame: From the first dose of study druguntil 60 days after the last dose
PD-L1 expression
The correlationship between PD-L1 expression and anti-tumor activity.
Time frame: Up to approximately 1.5 years.
Quality of Life Questionnaire
Change in Health-Related Quality of Life EORTC QLQ-C30
Time frame: Up to approximately 1.5 years.
Quality of Life Questionnaire
Change in Health-Related Quality of Life QLQ-LC13
Time frame: Up to approximately 1.5 years
Anti-drug antibodies (ADA)
Number and percentage of subjects with anti-drug antibodies (ADA) to SCTB14
Time frame: Up to approximately 1.5 years
Pharmacokinetic (PK)
Serum concentration of SCTB14 at different time points
Time frame: Up to approximately 1.5 years.