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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02726568
• Other study ID #: BD-IC-IV-65
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: December 2022

Study information

• Verified date: February 2019
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: YOU LU, M.D.
• Phone: 0086-28-85423571
• Email: radyoulu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histological or cytological confirmation of non-small cell lung cancer (NSCLC);

• Diagnosis of brain metastases on a Gadolinium-enhanced MRI.

• Less than 10 sites of intracranial metastases, or the longest diameter of the intracranial lesion is less than 4cm.

• Positive EGFR mutation(Ex19del or 21L858R).

• Life expectancy =3months.

• Have one or more measurable encephalic lesions according to RECIST.

• The patient has not received radiotherapy for the head or extracranial target lesions before.

• Adequate hematological function: Absolute neutrophil count (ANC) =1.5 x 109/L, and Platelet count =100 x 109/L.

• Adequate renal function: Serum creatinine =1.5 x ULN, or = 50 ml/min.

• Adequate liver function: Total bilirubin = 1.5 x upper limit of normal (ULN) and Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases.

• Female subjects should not be pregnant.

• All human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

• Written informed consent provided.

Exclusion Criteria:

• 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.

• Allergic to Icotinib.

• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.

• Pregnancy or breast-feeding women.

• Participate in the other anti-tumor clinical trials in 4 weeks.

• have quit from the trail before.

• Any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis
• Non-small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with treatment-related adverse events as assessed by NCI-CJ-CAE3.0		from date of randomization until the date of death, assessed up to 2 months.
Primary	intracranial progression-free survival		from date of randomization until the date of first documented intracranial progression, assessed up to 12 months.
Secondary	progress-free survival		from date of randomization until the date of extracranial progression, assessed up to 18 months.
Secondary	overall survival		from date of randomization until the date of death, assessed up to 36 months.
Secondary	objective response rate		from date of randomization until the date of progression, assessed up to 12 months.
Secondary	disease control rate		from date of randomization until the date of progression, assessed up to 18 months.
Secondary	Quality of life measured by FACT-L/LCS 4.0 and FACT-Br		from date of randomization until the date of death from any cause, assessed up to 36 months.