drugset / Trial / NCT03823807

A Study to Evaluate the Safety and Efficacy of SH-1028 in Locally Advanced or Metastatic NSCLC

NCT03823807

Phase 2 Unknown 300 enrolled Nanjing Sanhome Pharmaceutical, Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

A Phase II, Open Label, Single-arm Study to Assess the Safety and Efficacy of SH-1028 with Locally Advanced/Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene.

Timeline

Start
2019-03
Primary completion
2020-12
Completion
2021-03

Drugs

EvaluationDrugModalityDoseRoute
Subject ORITINIB Small molecule 100 mg Oral
Subject ORITINIB Small molecule 200 mg Oral