NCT02726568

High Dose Icotinib With Sequential SRS For NSCLC Patients Harboring EGFR Mutation With Brain Metastases

A Phase II Study to Determine the Efficacy and Safety of High Dose Icotinib Combined With Stereotatic Radiosurgery for NSCLC Patients Harboring EGFR Mutation With Brain Metastases

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trail is designed to assess the efficacy and safety of high dose Iconitib combined with SRS for NSCLC patients harboring EGFR mutation with brain metastases.

Detailed description

The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits to brain metastases patients.

Conditions

• Non-small Cell Lung Cancer
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Icotinib	375 mg Tid (1125 mg per day) until intracranial PD.
RADIATION	SRS	If intracranial PD, then the subjects get stereotatic radiosurgery （30Gy/3f) combined with Icotinib 375mg Tid.

Timeline

• Start date: 2016-03-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2016-04-01
• Last updated: 2019-02-19

Locations

1 site across 1 country: China