NCT04992858

Ningetinib in Advanced NSCLC Skipping Mutations With MET Exon 14 Skipping Mutations

A Phase II Study of the Ningetinib in Advanced NSCLC With MET Exon 14 Skipping Mutations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, Single-arm,Open-label Study evaluating the safety and efficacy of CT053PTSA in Advanced Solid Tumors With MET Exon 14 Skipping Mutations

Detailed description

This study is being carried out in two parts, part 1 and part 2. Part 1:Observation phase of dose tolerance: Objective To observe the tolerability and safety of 60 mg CT053PTSA in advanced NSCLC patients with Metex14 skipping mutation, and to determine the recommended dose (RED) in the dose expansion phase。 Part 2: This is the expansion part and will continue to evaluate the safety and efficacy of CT053PTSA at the dose of RED in advanced NSCLC patients with Metex14 skipping mutation.

Conditions

• Advanced NSCLC

Interventions

Type	Name	Description
DRUG	CT053PTSA	CT053PTSA will be administered orally once a day

Timeline

• Start date: 2022-11-27
• Primary completion: 2024-09-09
• Completion: 2024-12-09
• First posted: 2021-08-05
• Last updated: 2022-10-27