MedTrace Logo

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

NCT01951469 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2022-03-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Wu Jieping Medical Foundation

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01951469 on ClinicalTrials.gov