OncoMatch/Clinical Trials/NCT07362459
A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.
Is NCT07362459 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including SCTB14 and Pembrolizumab for non-small cell lung carcinoma (nsclc).
Treatment: SCTB14 · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR sensitizing mutation (wild-type)
confirmation of the absence of EGFR sensitizing mutations ... is required prior to enrollment
Required: ALK rearrangement (wild-type)
confirmation of the absence of ... ALK gene rearrangements ... is required prior to enrollment
Required: PD-L1 (CD274) overexpression (TPS ≥ 10%)
Subjects must provide a histology sample suitable for PD-L1 testing, with a Tumor Proportion Score (TPS) ≥ 10%
Required: ROS1 fusion (wild-type)
Known actionable driver gene mutations such as ROS1 fusion ... [excluded]
Required: BRAF V600E (wild-type)
Known actionable driver gene mutations such as ... BRAF V600E mutation ... [excluded]
Required: NTRK1 fusion (wild-type)
Known actionable driver gene mutations such as ... NTRK fusion ... [excluded]
Required: NTRK2 fusion (wild-type)
Known actionable driver gene mutations such as ... NTRK fusion ... [excluded]
Required: NTRK3 fusion (wild-type)
Known actionable driver gene mutations such as ... NTRK fusion ... [excluded]
Required: MET exon 14 skipping mutation (wild-type)
Known actionable driver gene mutations such as ... MET exon 14 skipping mutation ... [excluded]
Required: RET fusion (wild-type)
Known actionable driver gene mutations such as ... RET fusion mutation ... [excluded]
Disease stage
Required: Stage IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-tumor therapy
No prior systemic anti-tumor therapy for the studied disease
Cannot have received: antitumor immunotherapy
Prior treatment with antitumor immunotherapy
Cannot have received: antiangiogenic therapy
Prior treatment with ... antiangiogenic therapy
Cannot have received: small molecule tyrosine kinase inhibitor
Prior treatment with ... small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs
Cannot have received: thoracic radiotherapy
Prior thoracic radiotherapy
Cannot have received: local anti-tumor therapy
Exception: within 2 weeks before first dosing
local anti-tumor therapy within 2 weeks before first dosing
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07362459 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR sensitizing mutation is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK rearrangement is a required biomarker for enrollment.
Does this trial require CD274?
Yes, CD274 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIIB or IIIC or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify