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UNKNOWNPHASE4

Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study

NCT02103257•Betta Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)
•Patients must have previously untreated locally advanced or metastatic NSCLC
•EGFR activating mutation (exon 19 deletion, L858R) is required
•Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

Exclusion Criteria

•Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR
•Patients with wild-type EGFR
•Any other investigational agents are not permitted
•Any evidence of interstitial lung disease

Locations (31)

First Hospital of Lanzhou University

Lanzhou, Gansu, China

Lanzhou military region general hospital

Lanzhou, Gansu, China

General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, China

Cancer Hospital of Sun Yat-sen

Guangzhou, Guangdong, China

First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, China

Jiangmen central hospital

Jiangmen, Guangdong, China

The university of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Medical Oncology,Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Thoracic Surgery,Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Key Dates

Start Date

March 1, 2014

Primary Completion Date

March 1, 2016

Completion Date

September 1, 2017

Last Updated

April 29, 2015

Enrollment

192

ESTIMATED participants

Conditions

EGFR Positive Non-small Cell Lung CancerAdenocarcinoma

Interventions

Sequential Icotinib Plus Chemotherapy

DRUG

Icotinib

DRUG

Contacts

Helong Zhang, MD

CONTACT

13709202616

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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: April 29, 2015Data 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 Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

Inclusion Criteria

Exclusion Criteria

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

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

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