Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation

NCT01516983 | Completed Phase 1 DMC

• 1 other identifier: BD-IC-IV04
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR mutation.

Conditions

Non-small Cell Lung Cancer; Brain Metastases

Keywords

Safety; EGFR-TKI; NSCLC; Icotinib; WBRT

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  All cause adverse events (AEs) and serious adverse events (SAEs)

  6-12 months

Secondary Outcomes (6)

• Neurological progression-free survival

  3-6 month

• Progression-free survival

  3-6 months

• Overall survival

  6-12 months

• Response rate

  3-6 month

• Quality of life measured by FACT-L/LCS 4.0

  1 year

Study Arms (1)

Icotinib+WBRT

EXPERIMENTAL

Standard whole brain radiotherapy plus icotinib, which is designed to administered at 5 dose according to "3+3" until disease progression or intolerable toxicity.

Drug: icotinib; Radiation: Whole brain radiotherapy

Interventions

icotinib DRUG

Level 1: Standard whole brain radiation therapy plus icotinib 125 mg Tid (375 mg per day) from day1 until disease progression or intolerable toxicity. Level 2: Standard whole brain radiation therapy plus icotinib 250 mg Tid (750 mg per day) from day1 until disease progression or intolerable toxicity. Level 3: Standard whole brain radiation therapy plus icotinib 375 mg Tid (1125 mg per day) from day1 until disease progression or intolerable toxicity. Level 4:Standard whole brain radiation therapy plus icotinib 500 mg Tid (1500 mg per day) from day1 until disease progression or intolerable toxicity.

Also known as: BPI-2009, Conmana

Icotinib+WBRT

Whole brain radiotherapy RADIATION

Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.

Also known as: RT, XRT, Radiotherapy, WBRT

Icotinib+WBRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological confirmation of non-small cell lung cancer (NSCLC).
• Diagnosis of brain metastases on a Gadolinium-enhanced MRI. More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
• Positive EGFR mutation.

You may not qualify if:

• Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
• CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

icotinib; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• You Lu

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 25, 2012
• Study Start: December 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 17, 2014

Record last verified: 2014-02

Locations

CN (1)