Clinical trial NCT02726568: High Dose Icotinib With Sequential SRS For NSCLC Patients Harboring EGFR Mutation With Brain Metastases
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Brain Metastases
Keywords: EGFR-TKI
NSCLC
Icotinib
SRS
radiotherapy
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: intracranial progression-free survival
timeFrame: from date of randomization until the date of first documented intracranial progression, assessed up to 12 months.
Secondary outcomes:
measure: progress-free survival
timeFrame: from date of randomization until the date of extracranial progression, assessed up to 18 months.
measure: overall survival
timeFrame: from date of randomization until the date of death, assessed up to 36 months.
measure: objective response rate
timeFrame: from date of randomization until the date of progression, assessed up to 12 months.
measure: disease control rate
timeFrame: from date of randomization until the date of progression, assessed up to 18 months.
measure: Quality of life measured by FACT-L/LCS 4.0 and FACT-Br
timeFrame: from date of randomization until the date of death from any cause, assessed up to 36 months.
Other outcomes:
measure: Number of participants with treatment-related adverse events as assessed by NCI-CJ-CAE3.0
timeFrame: from date of randomization until the date of death, assessed up to 2 months.
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: YOU LU, M.D.
role: PRINCIPAL_INVESTIGATOR
References: