Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Progressed After Icotinib Treatment

A Phase II Randomised, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Icotinib in Combination With Chemotherapy Versus Chemotherapy Alone in Patients Who Have Progressed After Icotinib Treatment in NSCLC

This phase II randomised, double blind, placebo controlled, multicentre trial is designed to assess the efficacy and safety of continuous icotinib plus chemotherapy versus chemotherapy alone in patients who have progressed after benefiting from previous second or third-line icotinib treatment (more than 6 months) in locally advanced or metastatic non-small cell lung cancer.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Chemotherapy; Drug: Icotinib+chemotherapy

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

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410205
      • Active, not recruiting
      • Hunan Province Tumor Hospital
  • Zhejiang
    • 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
      • Active, not recruiting
      • Sir Run Run Shaw Hospital
    • Hangzhou, Zhejiang, China, 310000
      • Active, not recruiting
      • The First Affiliated Hospital of Medical School of Zhejiang University
    • Hangzhou, Zhejiang, China, 310000
      • Active, not recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Wenzhou, Zhejiang, China, 325000
      • Active, not recruiting
      • The First Affiliated Hospital of Wenzhou Medical College

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) 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: Chemotherapy; Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.	Drug: Chemotherapy; Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.; Other Names: Taxotere; ALIMTA
Experimental: Icotinib+Chemotherapy; Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.	Drug: Icotinib+chemotherapy; Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.; 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.	12 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): July 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): September 9, 2015
• Last Update Submitted That Met QC Criteria: September 5, 2015
• Last Verified: September 1, 2015

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-IC-IV44