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

Primary Purpose

NSCLC

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

icotinib

About this trial

This is an interventional treatment trial for NSCLC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Chest Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

21 icotinib (250mg)

21 icotinib (125mg)

19 icotinib (125mg)

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival

Objective response rates

Full Information

NCT ID

NCT02404675

First Posted

March 26, 2015

Last Updated

July 27, 2017

Sponsor

Betta Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02404675

Brief Title

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

Acronym

INCREASE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Betta Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

21 icotinib (250mg)

Arm Type

Experimental

Arm Description

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.

Arm Title

21 icotinib (125mg)

Arm Type

Active Comparator

Arm Description

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

Arm Title

19 icotinib (125mg)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

icotinib

Other Intervention Name(s)

conmana

Primary Outcome Measure Information:

Title

Progression-free survival

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

20 months

Title

Objective response rates

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhang Shucai, MD

Phone

010-89509304

sczhang6304@163.com

Facility Information:

Facility Name

Beijing Chest Hospital, Capital Medical University

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shucai Zhang, MD

Phone

86-10-89509304

sczhang6304@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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