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Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Advanced NSCLC

NCT02194556 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-07-18

No results posted yet for this study

Summary

This randomised, controlled, open-label, prospective trial is designed to assess the efficacy and safety of icotinib maintenance therapy after sequential Icotinib plus chemotherapy versus Icotinib maintenance therapy after chemotherapy in stage IIIB/IV non-small cell lung cancer patients with EGFR mutation.

Conditions

  • EGFR Positive Non-small Cell Lung Cancer
  • Adenocarcinoma

Interventions

DRUG

Sequential and maintenance icotinib

Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.

DRUG

Maintenance icotinib

Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg three times per day) until disease progression or intolerable toxicity.

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaohua Hu, MD · First Affiliated Hospital of Guangxi Medical University

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
2014-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

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 NCT02194556 on ClinicalTrials.gov