Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma
This study is currently recruiting participants.
Verified April 2013 by Zhejiang Beta Pharma Inc.
Sponsor:
Zhejiang Beta Pharma Inc.
Information provided by (Responsible Party):
Zhejiang Beta Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01665417
First received: August 12, 2012
Last updated: April 12, 2013
Last verified: April 2013
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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 Zhejiang Beta Pharma Inc.:
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: | February 2014 |
| Estimated Primary Completion Date: | August 2013 (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:
|
|
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:
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:
|
|
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:
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:
|
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
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
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
Zhejiang Beta Pharma Inc.
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: | Zhejiang Beta Pharma Inc. |
| ClinicalTrials.gov Identifier: | NCT01665417 History of Changes |
| Other Study ID Numbers: | BD-IC-IV08 |
| Study First Received: | August 12, 2012 |
| Last Updated: | April 12, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Zhejiang Beta Pharma Inc.:
|
Icotinib EGFR positive mutation First-line treatment Maintenance treatment |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Carcinoma, Bronchogenic |
Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013