EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC

Phase 3

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: EGFR-TKI; Radiation: whole brain radiotherapy

• Registration Number: NCT02714010
• Lead Sponsor: Sun Yat-sen University

Brief Summary

This is a multi-center phase III randomized controlled study, designing to access whether the efficacy of EGFR-TKI alone on patients with brain metastasis from non-small cell lung cancer (NSCLC) harboring EGFR mutant type is not inferior to EGFR-TKI concurrent with whole brain radiotherapy (WBRT), the primary end point is intracranial PFS (iPFS), while secondary outcomes included overall survival (OS), objective response rate (ORR), evaluation of cognitive function, quality of life (QoL) and adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-11-29
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 601

Inclusion Criteria

• Patients who was confirmed non-small cell lung cancer (NSCLC) by histology or cytology, harboring EGFR mutant type (19 and/or 21 exon mutation).
• Patients who was confirmed with asymptomatic, treatment naive brain metastasis (didn't receive any treatment after diagnosed with brain metastasis) by MRI, couldn't receive operation or stereotactic radiosurgery（SRS）.
• Appraisable disease, that is there must be at least one lesion with the longest diameter>10mm in brain (by brain MRI).
• Adult patients (18 to 75 years old). Eastern Cooperative Oncology Group（ECOG） performance status 0 to 2. Life expectancy of at least 12 weeks. Haemoglobin > 10g/dl, absolute neutrophil count (ANC) > 1.5 x 10^9/L, platelets > 100 x 10^9/L; total bilirubin < 1.5x upper limit of normal (ULN). Alanine aminotransferase（ALT） and aspartate aminotransferase（AST）< 1.5x ULN in the absence of liver metastases, or < 5x ULN in case of liver metastases. Creatinine clearance > 60ml/min (calculated according to Cockcroft-gault formula).
• Patients should be contraceptive during the period of the trial.

Exclusion Criteria

• Patients who had received brain radiotherapy or EGFR-TKI before.
• Patients who can't receive WBRT.
• Uncontrolled intracranial hypertension after steroid or dehydration therapy.
• Patients who take phenytoin, Carbamazepine, Rifampicin, Barbital, or St John's Wort which will interfere with the metabolism of TKI.
• Patients with interstitial lung disease, significant ocular disease, or serious uncontrolled systematic disease.
• Patients who can't take oral tablets, with active peptic ulcer diseases.
• Pregnancy or breast-feeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	EGFR-TKI	Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI
Arm 2	whole brain radiotherapy	Patients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI
Arm 1	EGFR-TKI	Patients take EGFR-TKI alone till tumor progression

Primary Outcome Measures

Name	Time	Method
intracranial PFS (iPFS)	up to 41 months	Compare intracranial PFS (iPFS) of two arms

Secondary Outcome Measures

Name	Time	Method
objective response rate (ORR)	up to 41 months
overall survival (OS)	up to 77 months

Trial Locations

Locations (1)

Sun Yat-sen University of cancer center; 🇨🇳 Guangzhou, Guangdong, China