Dose Escalation of Icotinib in Advanced Non-small Cell Lung Carcinoma (NSCLC) Patients Evaluated as Stable Disease
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
1 other identifier
interventional
180
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2012
Typical duration for phase_2
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 18, 2012
CompletedFirst Posted
Study publicly available on registry
September 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedDecember 30, 2014
December 1, 2013
3.2 years
September 18, 2012
December 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (3)
Overall survival
15 months
Transformation rate from stable disease to complete response or partial response
6 weeks
Incidence rate of adverse events
40 months
Study Arms (2)
Icotinib of Routine Dose
ACTIVE COMPARATOROral Drug icotinib 125 mg three times per day
Icotinib of High Dose
EXPERIMENTALOral Drug icotinib 250 mg three times per day
Interventions
Icotinib of routine dose: 125 mg is administered orally three times per day.
Icotinib: 250 mg is administered orally three times per day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Fujian Hospital for Chest Tumors & Tuberculosis Diseases
Fuzhou, Fujian, 350000, China
Fujian Provincal Hospital
Fuzhou, Fujian, 350001, China
Fujian Provincal Cancer Hospital
Fuzhou, Fujian, 350014, China
The second hospital of Xiamen City
Xiamen, Fujian, 361024, China
Hunan Provincal Cancer Hospital
Changsha, Hunan, 410006, China
The Second People's Hospital of Sichuan
Chengdu, Sichuan, 610041, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000, China
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang, 310000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
Zhejiang Traditional Chinese Medical Hospital
Hangzhou, Zhejiang, 310006, China
Zhejiang Hospital
Hangzhou, Zhejiang, 310007, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Yinzhou People's Hospital
Ningbo, Zhejiang, 315040, China
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, 315046, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang Yi Ping, M.D.
Zhejiang Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2012
First Posted
September 21, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2015
Study Completion
July 1, 2016
Last Updated
December 30, 2014
Record last verified: 2013-12