Back to results

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

Primary Purpose

Non-small Cell Lung Cancer, Brain Metastases

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Icotinib

SRS

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring EGFR-TKI, NSCLC, Icotinib, SRS, radiotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

West China HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib 375mg Tid

Arm Description

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

Outcomes

Primary Outcome Measures

intracranial progression-free survival

Secondary Outcome Measures

progress-free survival

overall survival

objective response rate

disease control rate

Quality of life measured by FACT-L/LCS 4.0 and FACT-Br

Full Information

NCT ID

NCT02726568

First Posted

March 29, 2016

Last Updated

February 15, 2019

Sponsor

Betta Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02726568

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Betta Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, Brain Metastases

Keywords

EGFR-TKI, NSCLC, Icotinib, SRS, radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Icotinib 375mg Tid

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Icotinib

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

SRS

Intervention Description

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

Primary Outcome Measure Information:

Title

intracranial progression-free survival

Time Frame

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

Secondary Outcome Measure Information:

Title

progress-free survival

Time Frame

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

Title

overall survival

Time Frame

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

Title

objective response rate

Time Frame

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

Title

disease control rate

Time Frame

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

Title

Quality of life measured by FACT-L/LCS 4.0 and FACT-Br

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Number of participants with treatment-related adverse events as assessed by NCI-CJ-CAE3.0

Time Frame

from date of randomization until the date of death, assessed up to 2 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

YOU LU, M.D.

Phone

0086-28-85423571

radyoulu@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

YOU LU, M.D.

Organizational Affiliation

West China Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

West China Hospital

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

YOU LU, M.D.

First Name & Middle Initial & Last Name & Degree

YOU LU, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs