Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
BD-IC-IV08
- NCT ID:
NCT01665417
Conditions
- EGFR Positive Non-small Cell Lung Cancer
- Adenocarcinoma
Interventions
| Drug | Synonyms | Arms |
|---|
| Experimental | BPI-2009, Commana | Experimental Icotinib |
| Chemotherapy | Pemetrexe, ALIMTA | Chemotherapy Regimen 1 |
| Chemotherapy | Docetaxel, Taxotere | Chemotherapy Regimen 1 |
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.
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
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Experimental Icotinib | Experimental | Icotinib: 125mg, oral administration, three times per day. | |
| Chemotherapy Regimen 1 | Active Comparator | 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 | Active Comparator | 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. | |
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
| Maximum Eligible Age: | 70 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Progression-free survival |
| Time Frame: | 8 months |
| Safety Issue: | |
| 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. |
Secondary Outcome Measures
| Measure: | Overall survival |
| Time Frame: | 24 months |
| Safety Issue: | |
| 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. |
| Measure: | Time to Tumor Progression |
| Time Frame: | 8 months |
| Safety Issue: | |
| Description: | 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. |
| Measure: | Objective response rate |
| Time Frame: | 3 months |
| Safety Issue: | |
| Description: | Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1. |
| Measure: | Number of participants with adverse events |
| Time Frame: | 24 months |
| Safety Issue: | |
| Description: | Adverse events assessed by CTCAE4.0. |
Details
| Phase: | Phase 4 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Betta Pharmaceuticals Co., Ltd. |
Trial Keywords
- Icotinib
- EGFR positive mutation
- First-line treatment
- Maintenance treatment
Last Updated
February 8, 2017
