A Study to Determine the Efficiency For Brain Metastasis NSCLC Patients Treated With Icotinib Alone or Combined With Radiation Therapy (SMART)

August 13, 2019 updated by: Betta Pharmaceuticals Co., Ltd.

A Multi-center, Prospective Study to Determine the Efficiency of Icotinib Combined With Radiation Therapy Early Intervention or Late Intervention For NSCLC Patients With Brain Metastases and EGFR(Epidermal Growth Factor Receptor) Mutation

The purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. The primary endpoint is overall survival .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. Some research show that icotinib combined with radiation therapy can improve the efficiency of NSCLC with brain metastases, but there is still controversial about the timing of radiation therapy intervention . This study is a prospective, multi-center, randomized, controlled trial of icotinib combined with early intervention or late intervention radiation therapy for NSCLC patients harboring EGFR mutation with brain metastases. They will be treated with icotinib and divided into 2 groups. Group 1: the radiation therapy will start within 1 month after icotinib treatment; Group2: the patients will be treated with icotinib first, radiation therapy intervene if disease progress.

Study Type

Interventional

Enrollment (Anticipated)

296

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological or cytological confirmation of non-small-cell lung cancer (NSCLC)
  • Positive EGFR mutation（Ex19del or 21L858R）
  • Primary diagnosis of brain metastases
  • Have one or more measurable encephalic lesions according to RECIST
  • Extracranial transfer organ≤3
  • ECGO:0-2
  • 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 : gefitinib, erlotinib, icotinib，or any other TKI
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early intervention
Icotinib is administered orally three times per day. Radiation therapy (SRS/ WBRT/ HA-WBRT/SMART) start in 1 month since take icotinib orally.
Drug: Icotinib
125mg Tid/375mg per day
Radiation: SRS/WBRT/HA-WBRT/SMART
>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS
Experimental: Late intervention
Icotinib is administered orally three times per day. Until emerge the progression of the disease, then is given radiation therapy (SRS/WBRT/HA-WBRT/SMART)
Drug: Icotinib
125mg Tid/375mg per day
Radiation: SRS/WBRT/HA-WBRT/SMART
>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: from date of randomization until the date of death, assessed up to 36 months.
from date of randomization until the date of death, assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival of intracranial lesions
Time Frame: from date of randomization until the date of progression, assessed up to 10 months
from date of randomization until the date of progression, assessed up to 10 months
disease control rate of intracranial lesions
Time Frame: from date of randomization until the date of progression, assessed up to 18 months
from date of randomization until the date of progression, assessed up to 18 months
Quality of life measured by FACT-L/LCS 4.0
Time Frame: from date of randomization until the date of death from any cause, assessed up to 36 months
measured by FACT-L/LCS 4.0
from date of randomization until the date of death from any cause, assessed up to 36 months
Neurocognitive function changes measured by MMSE
Time Frame: from date of randomization until the date of death from any cause, assessed up to 36 months
measured by MMSE
from date of randomization until the date of death from any cause, assessed up to 36 months
Observing acute and late toxicity assessed by CTCAE v4.0
Time Frame: from date of randomization until the date of death from any cause, assessed up to 36 months
Assessed by CTCAE v4.0
from date of randomization until the date of death from any cause, assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Betta Pharmaceuticals Co., Ltd.

Investigators

  • Principal Investigator: Chen Ming, Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 11, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (Actual)

August 15, 2019

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD-IC-IV99

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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