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

Sponsor

Betta Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01665417

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
EGFR Positive Non-small Cell Lung Cancer Adenocarcinoma	Drug: Experimental Drug: Chemotherapy Drug: Chemotherapy	Phase 4

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Icotinib Icotinib: 125mg, oral administration, three times per day.	Drug: Experimental Icotinib: 125mg, oral administration, three times per day. Other Names: BPI-2009 Commana
Active Comparator: Chemotherapy Regimen 1 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.	Drug: Chemotherapy 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. Other Names: Pemetrexe ALIMTA Drug: Chemotherapy 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. Other Names: Docetaxel Taxotere
Active Comparator: Chemotherapy Regimen 2 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.	Drug: Chemotherapy 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. Other Names: Pemetrexe ALIMTA Drug: Chemotherapy 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. Other Names: Docetaxel Taxotere

Arm

Intervention/Treatment

Experimental: Experimental Icotinib

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

Drug: Experimental

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

Other Names:

BPI-2009

Commana

Active Comparator: Chemotherapy Regimen 1

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.

Drug: Chemotherapy

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.

Other Names:

Pemetrexe

ALIMTA

Drug: Chemotherapy

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.

Other Names:

Docetaxel

Taxotere

Active Comparator: Chemotherapy Regimen 2

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.

Drug: Chemotherapy

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.

Other Names:

Pemetrexe

ALIMTA

Drug: Chemotherapy

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.

Other Names:

Docetaxel

Taxotere

Outcome Measures

Primary Outcome Measures

Progression-free survival [8 months]
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 [24 months]
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 [8 months]
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 [3 months]
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 [24 months]
Adverse events assessed by CTCAE4.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese People's Liberation Army (PLA) General Hospital	Beijing	Beijing	China	100853

Sponsors and Collaborators

Betta Pharmaceuticals Co., Ltd.

Investigators

Principal Investigator: Jiao Shunchang, MD, Chinese People's Liberation Army (PLA) General Hospital
Study Director: Fang Jian, MD, Peking University Cancer Hospital & Institute
Study Director: Bai Chunmei, MD, Peking Union Medical College Hospital
Study Director: Liu Wei, MD, Hebei Provincal Tumor Hospital