Clinical Trials /

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

NCT02714010

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: EGFR-TKI Concurrent With/Without WBRT in Brain Metastasis From NSCLC
  • Official Title: Whole Brain Radiotherapy Concurrent With EGFR-TKI Versus EGFR-TKI Alone in the Treatment of Non-small Cell Lung Cancer Patients With Brain Metastasis

Clinical Trial IDs

  • ORG STUDY ID: GASTO1014
  • NCT ID: NCT02714010

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
EGFR-TKIGefitinib/Tarceva/IcotinibArm 1

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalPatients take EGFR-TKI alone till tumor progression
  • EGFR-TKI
Arm 2Active ComparatorPatients take EGFR-TKI concurrent with whole brain radiotherapy (WBRT) till tumor progression, WBRT started within the first week of taking TKI
  • EGFR-TKI

Eligibility Criteria

        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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:intracranial PFS (iPFS)
Time Frame:up to 41 months
Safety Issue:
Description:Compare intracranial PFS (iPFS) of two arms

Secondary Outcome Measures

Measure:overall survival (OS)
Time Frame:up to 77 months
Safety Issue:
Description:
Measure:objective response rate (ORR)
Time Frame:up to 41 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sun Yat-sen University

Trial Keywords

  • EGFR-TKI
  • whole brain radiotherapy
  • brain metastasis
  • non-small cell lung cancer

Last Updated

October 25, 2017