NCT01951469

Gefitinib With or Without Chemotherapy in Brain Metastases From Non-small Cell Lung Cancer

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Gefitinib and Pemetrexed/platinum	Gefitinib 250mg is Taken Orally on day 1-28,combined Pemetrexed (D1)+cisplatin (D1-3) or Pemetrexed (D1) + nedaplatin (D1) chemotherapy, every 28 days
DRUG	Gefitinib mono-therapy	Gefitinib 250mg is Taken Orally everyday

Timeline

• Start date: 2016-01-01
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2013-09-26
• Last updated: 2022-03-08

Locations

1 site across 1 country: China