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

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.

Study Overview

• Status: Unknown
• Conditions: NSCLC
• Intervention / Treatment: Drug: Icotinib of routine dose; Drug: Icotinib of high dose

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhang Yi Ping, M.D.; Phone Number: 0086-13750881678; Email: zyp@medmail.com.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Recruiting
      • Fujian Hospital for Chest Tumors & Tuberculosis Diseases
      • Contact: Chen Qun, M.D.; Phone Number: 0086-13860669883
      • Principal Investigator: Chen Qun, M.D.
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Provincal Hospital
      • Contact: Cui Tongjian, M.D.; Phone Number: 0086-13905920326
      • Principal Investigator: Cui Tongjian, M.D.
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Provincal Cancer Hospital
      • Contact: Huang Cheng, M.D.; Phone Number: 0086-13905010397
      • Principal Investigator: Huang Cheng, M.D.
    • Xiamen, Fujian, China, 361024
      • Recruiting
      • The second hospital of Xiamen City
      • Contact: Ke Mingyao, M.D.; Phone Number: 0086-13860166866
      • Principal Investigator: Ke Mingyao, M.D.
  • Hunan
    • Changsha, Hunan, China, 410006
      • Recruiting
      • Hunan Provincal Cancer Hospital
      • Contact: Wu Lin, M.D.; Phone Number: 0086-13706671349
      • Principal Investigator: Wu Lin, M.D.
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • The Second People's Hospital of Sichuan
      • Contact: Yu Jingrui, M.D.; Phone Number: 0086-13551237583
      • Principal Investigator: Yu Jingrui, M.D.
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Lu Li Qin, M.D.; Phone Number: 0086-13858039628; Email: llq99999@yahoo.com.cn
      • Principal Investigator: Lu Li Qin, M.D.
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Zhang Yi Ping, M.D.; Phone Number: 0086-13750881678; Email: zyp@medmail.com.cn
      • Principal Investigator: Zhang Yi Ping, M.D.
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Sir Run Run Shaw Hospital
      • Contact: Pan Minghong, M.D.; Phone Number: 922 0086-57186006; Email: panhongming@tom.com
      • Principal Investigator: Pan Minghong, M.D.
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The second affiliated hospital of zhejiang university school of medicine
      • Contact: Huang Jianjin, M.D.; Phone Number: 0086-13989889688; Email: hhjj@medmail.com.cn
      • Principal Investigator: Huang Jianjin, M.D.
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital of Medical School of Zhejiang University
      • Contact: Zhou Jianying, M.D.; Phone Number: 0086-13750881678; Email: drzjy@163.com
      • Principal Investigator: Zhou Jianying, M.D.
    • Hangzhou, Zhejiang, China, 310006
      • Active, not recruiting
      • Zhejiang Traditional Chinese Medical Hospital
    • Hangzhou, Zhejiang, China, 310007
      • Active, not recruiting
      • Zhejiang Hospital
    • Ningbo, Zhejiang, China, 315040
      • Recruiting
      • Yinzhou People's Hospital
      • Contact: Guo Jianxin, M.D.; Phone Number: 0086-13605741696
      • Principal Investigator: Guo Jianxin, M.D.
    • Ningbo, Zhejiang, China, 315046
      • Recruiting
      • Ningbo Medical Treatment Center Lihuili Hospital
      • Contact: Shen Weiyu, M.D.; Phone Number: 0086-13805876129
      • Principal Investigator: Shen Weiyu, M.D.
    • Taizhou, Zhejiang, China, 317000
      • Recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: Hu Wei, M.D.; Phone Number: 0086-13606657129
      • Principal Investigator: Hu Wei, M.D.
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital Of WenZhou Medical College
      • Contact: Li Wenfeng, M.D.; Phone Number: 0086-13968840592
      • Principal Investigator: Li Wenfeng, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Icotinib of Routine Dose; Oral Drug icotinib 125 mg three times per day	Drug: Icotinib of routine dose; Icotinib of routine dose: 125 mg is administered orally three times per day.; Other Names: BPI-2009; Icotinib; Comana
Experimental: Icotinib of High Dose; Oral Drug icotinib 250 mg three times per day	Drug: Icotinib of high dose; Icotinib: 250 mg is administered orally three times per day.; Other Names: BPI-2009; Icotinib; Comana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	15 months
Transformation rate from stable disease to complete response or partial response	Number of participants with an stable disease previously achieve complete response or partial response after dose escalation. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.	6 weeks
Incidence rate of adverse events	Number of patients with a adverse event, identified according to the Common Toxicity Criteria (CTC) in evaluable-for-safety population, which included all patients who received at least 1 dose of study medication.	40 months

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Zhang Yi Ping, M.D., Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: September 18, 2012
• First Submitted That Met QC Criteria: September 20, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 26, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BD-IV-43