An Open ,Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease
18 Years
75 Years
Both
NSCLC
Trial Information
An Open ,Randomized, Multicenter, Phase II Trial to Evaluate the Safety and Efficacy of Dose Escalation of Icotinib in Advanced or Metastatic NSCLC Patients After 8 Weeks Routine Therapy Evaluated as Stable Disease
This is a multi-center phase II randomized controlled study to assess the safety and
efficacy of using high doses of the drug Icotinib (Conmana) as a way to treat patients with
non-small cell lung cancer that achieve stable disease after 8 weeks routine therapy by PFS,
as well as OS and DCR. The adverse events and adverse reaction are evaluated as well.
Inclusion Criteria:
- Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients
confirmed by sputum cytology)
- No previous targeted treatment such as gefitinib, erlotinib.
- With a measurable disease(longest diameters >=10mm with Spiral computed tomography
(CT)and >=20mm with conventional CT) at least according to RECIST Criteria
- WHO performance status(PS)<= 2
- N>=1.5×109/L, Plt>=1.0×109/L,Hb>=10g/dL;AST&ALT should <3ULN(without liver
metastasis) or <5ULN(with liver metastasis).TBIL<=1.5ULN.
- Signed and dated informed consent before the start of specific protocol procedures.
Exclusion Criteria:
- Allergic to icotinib
- Patients with metastatic brain tumors with symptoms.
- Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or
small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
- Severe systemic disease out of control such as unstable or uncompensated
respiratory,cardiac,liver,renal diseases.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Description:
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.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Zhang Yi Ping, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Zhejiang Cancer Hospital
Authority:
China: Food and Drug Administration
Study ID:
BD-IV-43
NCT ID:
NCT01690390
Start Date:
September 2012
Completion Date:
December 2015
Related Keywords:
- NSCLC
- Carcinoma, Non-Small-Cell Lung
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