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UNKNOWNPHASE4

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

Sequential and Maintenance Icotinib Plus Chemotherapy Versus Icotinib Maintenance After Chemotherapy in Untreated Advanced Non-small-cell Lung Cancer: a Randomized, Open-label Study

NCT02194556•Betta Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Stage IV or IIIB advanced non-small cell lung cancer patients
•Positive EGFR Mutation
•Non-progressive disease after first-line gemcitabine/cisplatin therapy
•Measurable lesion according to RECIST 1.1 with at least one measurable lesion

Exclusion Criteria

•Previous anti-EGFR (epidermal growth factor receptor) monoclonal antibody or small molecular agent such as gefitinib, erlotinib and so on
•Patients with wild-type EGFR
•Evidence of interstitial lung diseases
•Severe hypersensitivity to icotinib or any of the excipients of this product.
•Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

Locations (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Key Dates

Start Date

July 1, 2014

Primary Completion Date

July 1, 2017

Completion Date

July 1, 2017

Last Updated

July 18, 2014

Enrollment

100

ESTIMATED participants

Conditions

EGFR Positive Non-small Cell Lung CancerAdenocarcinoma

Interventions

Sequential and maintenance icotinib

DRUG

Maintenance icotinib

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors