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Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Primary Purpose

EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Experimental

Chemotherapy

About this trial

This is an interventional treatment trial for EGFR Positive Non-small Cell Lung Cancer focused on measuring Icotinib, EGFR positive mutation, First-line treatment, Maintenance treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R).

Exclusion Criteria:

Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease

Sites / Locations

Chinese People's Liberation Army (PLA) General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Icotinib

Chemotherapy Regimen 1

Chemotherapy Regimen 2

Arm Description

Icotinib: 125mg, oral administration, three times per day.

Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression-free survival

PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.

Secondary Outcome Measures

Overall survival

OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.

Time to Tumor Progression

TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.

Objective response rate

Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1.

Number of participants with adverse events

Adverse events assessed by CTCAE4.0.

Full Information

NCT ID

NCT01665417

First Posted

August 12, 2012

Last Updated

February 7, 2017

Sponsor

Betta Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01665417

Brief Title

Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Official Title

Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

July 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Betta Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Detailed Description

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib. Primary endpoint: Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib Secondary endpoint: Overall survival between icotinib and chemotherapy Time to Progression between icotinib and chemotherapy Objective response rate and disease control rate between icotinib and chemotherapy

6. Conditions and Keywords

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

EGFR Positive Non-small Cell Lung Cancer, Adenocarcinoma

Keywords

Icotinib, EGFR positive mutation, First-line treatment, Maintenance treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental Icotinib

Arm Type

Experimental

Arm Description

Icotinib: 125mg, oral administration, three times per day.

Arm Title

Chemotherapy Regimen 1

Arm Type

Active Comparator

Arm Description

Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Arm Title

Chemotherapy Regimen 2

Arm Type

Active Comparator

Arm Description

Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Intervention Type

Drug

Intervention Name(s)

Experimental

Other Intervention Name(s)

BPI-2009, Commana

Intervention Description

Icotinib: 125mg, oral administration, three times per day.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Other Intervention Name(s)

Pemetrexe, ALIMTA

Intervention Description

Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Other Intervention Name(s)

Docetaxel, Taxotere

Intervention Description

Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.

Time Frame

8 months

Secondary Outcome Measure Information:

Title

Overall survival

Description

OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.

Time Frame

24 months

Title

Time to Tumor Progression

Description

Time Frame

8 months

Title

Objective response rate

Description

Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1.

Time Frame

3 months

Title

Number of participants with adverse events

Description

Adverse events assessed by CTCAE4.0.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R). Exclusion Criteria: Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease

Central Contact Person:

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

Jiao Shunchang, MD

Phone

0086-13801380677

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiao Shunchang, MD

Organizational Affiliation

Chinese People's Liberation Army (PLA) General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fang Jian, MD

Organizational Affiliation

Peking University Cancer Hospital & Institute

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Bai Chunmei, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Liu Wei, MD

Organizational Affiliation

Hebei Provincal Tumor Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Chinese People's Liberation Army (PLA) General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jiao Shunchang, MD

Phone

0086-13801380677

First Name & Middle Initial & Last Name & Degree

Jiao Shunchang, MD

12. IPD Sharing Statement

Learn more about this trial

Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

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