Clinical trial NCT01690390: Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
Official title: An Open-label, 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purposes of this study are 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: 15 months
measure: Transformation rate from stable disease to complete response or partial response
timeFrame: 6 weeks
measure: Incidence rate of adverse events
timeFrame: 40 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Hospital for Chest Tumors & Tuberculosis Diseases
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincal Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincal Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: The second hospital of Xiamen City
state: Fujian
city: Changsha
country: China
facility: Hunan Provincal Cancer Hospital
state: Hunan
city: Chengdu
country: China
facility: The Second People's Hospital of Sichuan
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Medical School of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Traditional Chinese Medical Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Yinzhou People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Medical Treatment Center Lihuili Hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Zhang Yi Ping, M.D.
role: PRINCIPAL_INVESTIGATOR
References: