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Pemetrexed Combined With Synchronous Gefitinib as Adjuvent Therapy in Patient With EGFR Mutant Lung Adenocarcinoma

NCT02518802 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2015-08-10

No results posted yet for this study

Summary

This randomized phase III trial is studying gefitinib and synchronous pemetrexed/cisplatin chenmotherapy to see how well it works compared to pemetrexed/cisplatin chenmotherapy alone in treating patients who have undergone surgery for stage II-IIIA(N1-N2) lung adenocarcinoma with EGFR activating mutation in Asian population.

Conditions

  • Lung Neoplasms

Interventions

DRUG

Gefitinib

Gefitinib 250mg per day for 2 years.

DRUG

Pemetrexed

Pemetrexed, 500mg/m2, day 1; Cisplatin 75mg/m2, day 1. Three weeks as a cycle. Four cycles in total.

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Principal Investigators

  • Li Xiaofei, MD · Tangdu Hospital of the Fourth Millitary Medical University

  • Yan Xiaolong, MD · Tangdu Hospital of the Fourth Millitary Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-01-31
Completion
2020-01-31

Countries

  • China

Study Locations

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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 NCT02518802 on ClinicalTrials.gov