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
Qualifiers
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
Treatments tested in this trial
- SCTB14
- Pembrolizumab
Treatment groups
246 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov