Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR

An Open-label,Randomized,Controlled Study to Evaluate the Safety and Efficacy for Icotinib at Different Doses in Second-line Treatment for Non-small Cell Lung Cancer Patients With Wild Type EGFR

This study is designed to evaluate the safety and efficacy of icotinib at routine dose and higher dose as second-line treatment in non-small cell lung cancer patients with epidermal growth factor receptor of wild type.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Icotinib of routine dose; Drug: Icotinib of high dose

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
      • Contact: Changli Wang; Email: wangchangli@medmail.com.cn

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:

• Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients with Histologic or cytologic confirmation.
• Wild type epidermal growth factor receptor status.
• Progressed after first-line chemotherapy.
• No previous systemic anticancer therapy.
• Measurable lesion according to response evaluation criteria in solid tumors with at least one measurable lesion not previously irradiated.
• Provision of written informed consent.

Exclusion Criteria:

• Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
• Positive epidermal growth factor receptor mutation.
• Known severe hypersensitivity to icotinib or any of the excipients of this product.
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Icotinib of routine dose; Icotinib: 125mg, oral administration, three times per day.	Drug: Icotinib of routine dose; Icotinib: 125mg, oral administration, three times per day.; Other Names: BPI-2009; Conmana
EXPERIMENTAL: Icotinib of high dose; Icotinib: 375mg, oral administration, three times per day.	Drug: Icotinib of high dose; Icotinib: 375mg, oral administration, three times per day.; Other Names: BPI-2009; Conmana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, confirmed at least 28 days following the date of the initial response.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Progression free survival was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.	3 months
Overall survival	Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive.	14 months
Number of Participants with Adverse Events	Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.	18 months

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: Changli Wang, M.D., Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ANTICIPATED): November 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: December 5, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (ESTIMATE): December 7, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: August 1, 2012

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-IV26