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

Non Small Cell Lung Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04058704
• Other study ID #: BD-IC-IV99
• Status: Recruiting
• Phase: Phase 3
• Start date: July 20, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2019
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: Chen Ming
• Phone: +86 18758875572
• Email: chenming[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 296
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Neoplasm Metastasis
• Non Small Cell Lung Cancer

Intervention

Drug:
• Icotinib
125mg Tid/375mg per day

Radiation:
• SRS/WBRT/HA-WBRT/SMART
>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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