High Dose Icotinib With Sequential SRS For NSCLC Patients Harboring EGFR Mutation With Brain Metastases

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This trail is designed to assess the efficacy and safety of high dose Iconitib combined with SRS for NSCLC patients harboring EGFR mutation with brain metastases.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.

Criteria

Inclusion Criteria:

• Histological or cytological confirmation of non-small cell lung cancer (NSCLC);

• Diagnosis of brain metastases on a Gadolinium-enhanced MRI.

• Less than 10 sites of intracranial metastases, or the longest diameter of the intracranial lesion is less than 4cm.

• Positive EGFR mutation（Ex19del or 21L858R）.

• Life expectancy ≥3months.

• Have one or more measurable encephalic lesions according to RECIST.

• The patient has not received radiotherapy for the head or extracranial target lesions before.

• 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 or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.

• 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.