Overview

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.