drugset / Trial / NCT03758287

Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative

NCT03758287

Phase 1/2 Completed 108 enrolled Sunshine Lake Pharma Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

This is a phase Ib, multi-center, open label study evaluating the safety and efficacy of CT053PTSA in combination with gefitinib in patients with EGFR mutation, T790M negative NSCLC who have progressed after EGFR TKI treatment.

Timeline

Start
2016-11
Primary completion
2021-09-17
Completion
2021-09-17

Drugs

EvaluationDrugModalityDoseRoute
Subject CT053PTSA Unknown 30 mg Oral
Subject CT053PTSA Unknown 40 mg Oral
Subject CT053PTSA Unknown 60 mg Oral
Subject Gefitinib Small molecule 250 mg Oral