drugset / Trial / NCT05020769

SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.

NCT05020769

Phase 2/3 Active not recruiting 14 enrolled Sichuan Baili Pharmaceutical Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

Summary

This multi-center, open label Phase II/III clinical study is performed in patients with locally advanced/metastatic NSCLC progressed on prior EGFR-TKI treatment or with non TKI-sensitizing mutation or patients with EGFR exon20ins mutation. This study is investigating the safety and efficacy of SI-B001 at monotherapy RP2D or lower combined with Osimertinib in patients with locally advanced or metastatic NSCLC.

Timeline

Start
2022-01-06
Primary completion
2025-12
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject IZALONTAMAB Monoclonal antibody Intravenous
Subject Osimertinib Small molecule 80 mg