A Phase 4 interventional study of Experimental and Chemotherapy in EGFR Positive Non-small Cell Lung Cancer and Adenocarcinoma, sponsored by Betta Pharmaceuticals Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-02-08.
Sponsored by Betta Pharmaceuticals Co., Ltd. · Phase 4, Interventional, and Treatment
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.
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:
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's planned enrollment of 100 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Betta Pharmaceuticals Co., Ltd. is the lead sponsor of 79 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Icotinib: 125mg, oral administration, three times per day.
Drug: Experimental
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 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
Icotinib: 125mg, oral administration, three times per day.
Also known as: BPI-2009, Commana
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.
Also known as: Pemetrexe, ALIMTA
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.
Also known as: Docetaxel, Taxotere
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.
Time frame: 8 months
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 frame: 24 months
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.
Time frame: 8 months
Objective response rate
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
Number of participants with adverse events
Adverse events assessed by CTCAE4.0.
Time frame: 24 months
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Betta Pharmaceuticals Co., Ltd.