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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 (May 2026). This Phase 3 trial studies multiple treatments including SCTB14 and Pembrolizumab for non-small cell lung carcinoma (nsclc).

Phase 3RecruitingSinocelltech Ltd.NCT07362459Data as of May 2026

Treatment: SCTB14 · PembrolizumabThis 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.

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Extracted eligibility criteria

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

No prior treatment (treatment-naive required)
Max 0 prior lines

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.

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