Icotinib Combined With Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation

Betta Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Brain Metastases; Non-Small Cell Lung Cancer

Treatments: Drug: Icotinib; Radiation: WBRT or SRS

Study type: Interventional

Funder types: Industry

Identifiers

NCT03754530

2018-007-02

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of icotinib in combination with radiotherapy for NSCLC patients with brain metastases. The primary endpoint is PFS of intracranial lesions

Full description

Non-small cell lung cancer (NSCLC) is one of the malignant tumors with the highest incidence of brain metastases. Patients with brain metastasis showed poor prognosis and displayed an untreated median survival of only 3-6 months, and most patients died due to the progression of brain metastases. Some research showed that Icotinib alone can improve the efficiency of NSCLC with brain metastases, but there is still unknow about the result about combination with EGFR-TKI and radiotherapy. This study is designed to evaluate the efficacy of icotinib combined with radiotherapy for NSCLC patients with brain metastases.

Enrollment: 162 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) with brain metastases
• Histological or cytological confirmation of EGRF positive sensitive mutation
• Diagnosis of brain metastases on a Gadolinium-enhanced MRI

Exclusion criteria

• Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux
• Previous usage of radiation with brain
• CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Icotinib

Experimental group

Description:

icotinib is administered orally three times per day. Until emerge the progression of the intracranial disease, then is given radiotherapy(\>3 with WBRT or \<=3 with SRS) after PD

Treatment:

Drug: Icotinib

Icotinib plus radiation therapy

Experimental group

Description:

Standard whole brain radiotherapy (WBRT) is given with 30GY/10 times(\>3), or SRS(\<=3) plus concurrent icotinib, which was administered orally three times per day. Until the disease progresses.

Treatment:

Radiation: WBRT or SRS

Drug: Icotinib