A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily sign the written informed consent form prior to screening.
Age ≥ 18 years, both male and female.
ECOG Performance Status score of 0 to 1.
An expected survival of ≥ 3 months.
Disqualifiers
Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.
Received non-specific immunomodulatory therapy or immunosuppressive drugs within 2 weeks before the first dose; received traditional Chinese medicine with antineoplastic indications within 1 week before the first dose.
Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.
Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.
Trial design
Design model
Parallel
Treatments tested in this trial
SCTB14
DrugSCTB14 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle.
Pembrolizumab
DrugPembrolizumab is administered at a fixed dose of 200 mg by intravenous infusion on Day 1 of each 3-week cycle.
Treatment groups
246 Participants
are divided into 2 treatment groupsGroup A: SCTB14Experimental treatment 1 intervention
Group B: PembrolizumabActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression-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 yearsSecondary outcomes
1
overall survival
The time from the date of randomization to the date of death from any cause.
Time frame
Up to approximately 5 years2
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 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov