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

Sponsor

Betta Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02726568

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer Brain Metastases	Drug: Icotinib Radiation: SRS	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Icotinib 375mg Tid The human subject gets icotinib 375mg, Tid until intracranial PD or intolerable toxicity reaction.	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.

Arm

Intervention/Treatment

Experimental: Icotinib 375mg Tid

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

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.

Outcome Measures

Primary Outcome Measures

intracranial progression-free survival [from date of randomization until the date of first documented intracranial progression, assessed up to 12 months.]

Secondary Outcome Measures

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 Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.