Multicenter Phase III Study of Gefitinib Mono-therapy or Gefitinib Combined With Chemotherapy in Patients With Brain Metastases From Non-small Cell Lung Cancer Harboring EGFR Mutation

NCT01951469 Phase 3 UNKNOWN

This is a multi-center phase III randomized controlled study to assess the efficacy of Gefitinib alone and Gefitinib combination with Pemetrexed/platinum on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.

Details

Lead sponsor	Sun Yat-sen University
Phase	Phase 3
Status	UNKNOWN
Enrolment	160
Start date	2016-01
Completion	2022-12

Conditions

• Non-small Cell Lung Cancer
• Brain Metastases
• EGFR Mutation

Interventions

• Gefitinib and Pemetrexed/platinum
• Gefitinib mono-therapy

Primary outcomes

• iPFS(intracranial progression free survival — 2 years
  defined as time from randomization to intracranial progressive disease or death.

Countries

China