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

Betta Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Brain Metastases; Non Small Cell Lung Cancer

Treatments: Radiation: SRS/WBRT/HA-WBRT/SMART; Drug: Icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04058704

BD-IC-IV99

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 296 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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296 participants in 2 patient groups

Early intervention

Experimental group

Description:

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

Treatment:

Drug: Icotinib

Radiation: SRS/WBRT/HA-WBRT/SMART

Late intervention

Experimental group

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)

Treatment:

Drug: Icotinib

Radiation: SRS/WBRT/HA-WBRT/SMART