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

Primary Purpose

Non Small Cell Lung Cancer, Brain Metastases

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Icotinib

SRS/WBRT/HA-WBRT/SMART

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring EGFR-TKI, NSCLC, Icotinib, 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)
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.

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Early intervention

Late intervention

Arm Description

Icotinib is administered orally three times per day. Radiation therapy (SRS/ WBRT/ HA-WBRT/SMART) start in 1 month since take icotinib orally.

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)

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progression-free survival of intracranial lesions

disease control rate of intracranial lesions

Quality of life measured by FACT-L/LCS 4.0

measured by FACT-L/LCS 4.0

Neurocognitive function changes measured by MMSE

measured by MMSE

Observing acute and late toxicity assessed by CTCAE v4.0

Assessed by CTCAE v4.0

Full Information

NCT ID

NCT04058704

First Posted

August 11, 2019

Last Updated

August 13, 2019

Sponsor

Betta Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04058704

Brief Title

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

Acronym

SMART

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 20, 2018 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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 .

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.

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, radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

296 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early intervention

Arm Type

Experimental

Arm Description

Icotinib is administered orally three times per day. Radiation therapy (SRS/ WBRT/ HA-WBRT/SMART) start in 1 month since take icotinib orally.

Arm Title

Late intervention

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Icotinib

Intervention Description

125mg Tid/375mg per day

Intervention Type

Radiation

Intervention Name(s)

SRS/WBRT/HA-WBRT/SMART

Intervention Description

>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

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

Secondary Outcome Measure Information:

Title

Progression-free survival of intracranial lesions

Time Frame

from date of randomization until the date of progression, assessed up to 10 months

Title

disease control rate of intracranial lesions

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

Description

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

Title

Neurocognitive function changes measured by MMSE

Description

measured by MMSE

Time Frame

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

Title

Observing acute and late toxicity assessed by CTCAE v4.0

Description

Assessed by CTCAE v4.0

Time Frame

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

Central Contact Person:

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

Chen Ming

Phone

+86 18758875572

chenming@zjcc.org.cn

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

Wang Jin

Phone

+86 18858165856

wangjin@zjcc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chen Ming

Organizational Affiliation

Zhejiang Cancer Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chen Ming

chenming@zjcc.org.cn

First Name & Middle Initial & Last Name & Degree

Wang Jin

wangjin@zjcc.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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