SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)

NCT06208033 ↗

Phase 0 Unknown 40 enrolled Fujian Cancer Hospital

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a single-arm, sequential study assessing the efficacy and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced non-small cell lung cancer (NSCLC) : first-line treatment or failed from first-line immune checkpoint inhibitor treatment.The primary objective is to evaluate the anti-tumor activity and safety of SMET12 and Toripalimab combined chemotherapy in patients with EGFR positive advanced NSCLC.

Timeline

Start: 2024-01-10
Primary completion: 2024-10-20
Completion: 2024-12-30

Publications

Lin J, Chen S, Li M, Weng L, Xu H, Wang Q, Zhang J, Lin D, Wang H, Liu Q, He Z. Efficacy and safety of SMET12 in combination with toripalimab and chemotherapy in advanced non-small-cell lung cancer patients tested positive for EGFR protein who are treatment-naive or harbor acquired resistance to standard therapy: a phase 2, multi-cohort clinical trial. Front Immunol. 2026 Jan 8;16:1706961. doi: 10.3389/fimmu.2025.1706961. eCollection 2025.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Carboplatin	Small molecule	500 mg/m2	—
Subject	Cisplatin	Other / unclassified	75 mg/m2	—
Subject	Docetaxel	Small molecule	60 mg/m2	—
Subject	Docetaxel	Small molecule	75 mg/m2	—
Subject	Paclitaxel	Small molecule	60 ug	Intravenous
Subject	Paclitaxel	Small molecule	100 mg/m2	—
Subject	Pemetrexed	Small molecule	500 mg/m2	—
Subject	Toripalimab	Monoclonal antibody	3 mg/kg	Intravenous

SMET12 and Toripalimab Combined Chemotherapy in Patients With EGFR Positive Advanced Non-small Cell Lung Cancer (NSCLC)

Summary

Timeline

Publications

Drugs

Indications