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

NCT02726568 | Unknown Phase 2

• 1 other identifier: BD-IC-IV-65
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer; Brain Metastases

Keywords

EGFR-TKI; NSCLC; Icotinib; SRS; radiotherapy

Outcome Measures

Primary Outcomes (1)

• intracranial progression-free survival

  from date of randomization until the date of first documented intracranial progression, assessed up to 12 months.

Secondary Outcomes (5)

• progress-free survival

  from date of randomization until the date of extracranial progression, assessed up to 18 months.

• overall survival

  from date of randomization until the date of death, assessed up to 36 months.

• objective response rate

  from date of randomization until the date of progression, assessed up to 12 months.

• disease control rate

  from date of randomization until the date of progression, assessed up to 18 months.

• 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.

Other Outcomes (1)

• 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.

Study Arms (1)

Icotinib 375mg Tid

EXPERIMENTAL

The human subject gets icotinib 375mg, Tid until intracranial PD or intolerable toxicity reaction.

Drug: Icotinib; Radiation: SRS

Interventions

Icotinib DRUG

375 mg Tid (1125 mg per day) until intracranial PD.

Icotinib 375mg Tid

SRS RADIATION

If intracranial PD, then the subjects get stereotatic radiosurgery （30Gy/3f) combined with Icotinib 375mg Tid.

Icotinib 375mg Tid

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.
• 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.

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.
• 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.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

icotinib

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

Study Officials

• YOU LU, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YOU LU, M.D.

CONTACT

0086-28-85423571; radyoulu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 1, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

CN (1)