A Phase 4 interventional study of Sequential Icotinib Plus Chemotherapy and Icotinib in EGFR Positive Non-small Cell Lung Cancer and Adenocarcinoma, sponsored by Betta Pharmaceuticals Co., Ltd.. Status unknown at 31 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-29.
Sponsored by Betta Pharmaceuticals Co., Ltd. · Phase 4, Interventional, and Treatment
This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's planned enrollment of 192 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:
Sequential icotinib plus chemotherapy : pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Drug: Sequential Icotinib Plus Chemotherapy
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
Drug: Icotinib
Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Also known as: ALIMTA, DDP, Comana, BPI-2009
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
Also known as: Comana, BPI-2009
Progression Free Survival
A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.
Time frame: 15 months
Overall survival
Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.
Time frame: 24 months
Objective response rate
Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Time frame: 15 months
Adverse events
The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Time frame: 24 months
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Betta Pharmaceuticals Co., Ltd.