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High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE)

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ClinicalTrials.gov Identifier: NCT02404675
Recruitment Status : Unknown
Verified July 2017 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 31, 2015
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Brief Summary:
This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.

Condition or disease Intervention/treatment Phase
NSCLC Drug: icotinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE): a Randomized, Open-label Study
Study Start Date : April 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 21 icotinib (250mg)
Patients with EGFR 21 exon positive are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 250 mg three times per day, till progressive disease or unaccepted toxicity.
Drug: icotinib
Other Name: conmana

Active Comparator: 21 icotinib (125mg)
Patients with EGFR 21 exon positive are randomly assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
Drug: icotinib
Other Name: conmana

Experimental: 19 icotinib (125mg)
Patients with EGFR del 19 exon positive are assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
Drug: icotinib
Other Name: conmana




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 20 months ]
  2. Objective response rates [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology)
  • Positive EGFR 21 exon mutation or 19 exon deletion
  • Age 18-75 years old with performance status of 0 to 2
  • With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria
  • Adequate hematological, biochemical and organ functions.

Exclusion Criteria:

  • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
  • Evidence of interstitial lung diseases
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404675


Contacts
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Contact: Zhang Shucai, MD 010-89509304 sczhang6304@163.com

Locations
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China
Beijing Chest Hospital, Capital Medical University Recruiting
Beijing, China
Contact: Shucai Zhang, MD    86-10-89509304    sczhang6304@163.com   
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.

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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02404675     History of Changes
Other Study ID Numbers: AKTN-NSCLC-01
First Posted: March 31, 2015    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases