SCTB41 Combined With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
ConditionDouble Blind
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSinocelltech Ltd.
About this trial
This is a multicenter Phase II/III study evaluating the efficacy and safety of SCTB41 combined with chemotherapy versus tislelizumab combined with chemotherapy as first-line treatment in patients with driver-negative locally advanced or metastatic non-small cell lung cancer (NSCLC).
The Phase II portion is an open-label safety run-in study enrolling approximately 30-60 patients to evaluate the safety and tolerability of SCTB41 plus chemotherapy. Following confirmation of acceptable safety and preliminary efficacy, the study will proceed to the Phase III portion.
The Phase III portion is a randomized, double-blind, active-controlled study enrolling approximately 350 patients. Eligible participants will be randomized in a 1:1 ratio to receive SCTB41 plus chemotherapy or tislelizumab plus chemotherapy. The primary objective is to compare progression-free survival assessed by blinded independent central review according to RECIST version 1.1.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary written informed consent (ICF) signed prior to screening.
Age ≥18 years, male or female.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Expected survival ≥3 months.
Disqualifiers
Known ROS1 fusion-positive, BRAF V600E mutation, or other driver mutations for which guideline-recommended first-line targeted therapies are available.
Prior thoracic radiotherapy.
Symptomatic central nervous system metastases.
Imaging evidence during screening showing tumor invasion of major blood vessels, invasion of critical surrounding organs, or risk of tracheoesophageal fistula or esophagopleural fistula as assessed by the investigator.
Trial design
Design model
Parallel
Treatments tested in this trial
SCTB41
DrugIV infusion,Specified dose on specified days.
Tislelizumab
DrugIV infusion,Specified dose on specified days.
Paclitaxel
Drug175 mg/m², IV infusion, Q3W, for 4 cycles.
Nab-paclitaxel
Drug100 mg/m², IV infusion, on Days 1, 8, 15 of each 3-week cycle, for 4 cycles
Carboplatin
DrugAUC 5, IV infusion, Q3W, for 4 cycles.
Cisplatin
Drug75 mg/m², IV infusion, Q3W, for 4 cycles.
Pemetrexed
Drug500 mg/m², IV infusion, Q3W, for 4 cycles .
Treatment groups
410 Participants
are divided into 2 treatment groupsGroup A: SCTB41 + ChemotherapyExperimental treatment 6 interventions
Group B: Tislelizumab + ChemotherapyActive comparator 6 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first).
Time frame
Up to approximately 24 months.Sponsors and contacts
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Source ClinicalTrials.gov