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

Study Purpose

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 .

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04058704
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Betta Pharmaceuticals Co., Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chen Ming
Principal Investigator Affiliation Zhejiang Cancer Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non Small Cell Lung Cancer, Brain Metastases
Additional Details

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.

Arms & Interventions

Arms

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.

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)

Interventions

Drug: - Icotinib

125mg Tid/375mg per day

Radiation: - SRS/WBRT/HA-WBRT/SMART

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Zhejiang Cancer Hospital

Hangzhou, Zhejiang,

Site Contact

Chen Ming

chenming@zjcc.org.cn

+86 18758875572