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

NSCLC Clinical Trial

— INCREASE  

Official title:

High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE): a Randomized, Open-label Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02404675
• Other study ID #: AKTN-NSCLC-01
• Status: Recruiting
• Phase: Phase 4
• First received: March 26, 2015
• Last updated: July 27, 2017
• Start date: April 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2017
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Zhang Shucai, MD
• Phone: 010-89509304
• Email: sczhang6304[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

Drug:
• icotinib

Locations

Country	Name	City	State
China	Beijing Chest Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		12 months
Secondary	Overall survival		20 months
Secondary	Objective response rates		12 weeks