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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Betta Pharmaceuticals Co.,Ltd.
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01665417
First received: August 12, 2012
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
EGFR Positive Non-small Cell Lung Cancer
Adenocarcinoma
Drug: Experimental
Drug: Chemotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Betta Pharmaceuticals Co.,Ltd.:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Adverse events assessed by CTCAE4.0.


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

  1. Overall survival between icotinib and chemotherapy
  2. Time to Progression between icotinib and chemotherapy
  3. Objective response rate and disease control rate between icotinib and chemotherapy
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665417

Contacts
Contact: Jiao Shunchang, MD 0086-13801380677

Locations
China, Beijing
Chinese People's Liberation Army (PLA) General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Jiao Shunchang, MD    0086-13801380677      
Principal Investigator: Jiao Shunchang, MD         
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 Beijing Cancer Hospital
Study Director: Bai Chunmei, MD Peking Union Medical College Hospital
Study Director: Liu Wei, MD Hebei Provincal Tumor Hospital
  More Information

No publications provided

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01665417     History of Changes
Other Study ID Numbers: BD-IC-IV08
Study First Received: August 12, 2012
Last Updated: May 7, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Betta Pharmaceuticals Co.,Ltd.:
Icotinib
EGFR positive mutation
First-line treatment
Maintenance treatment

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014