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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01744925
• Other study ID #: BD-IC-IV26
• Status: Recruiting
• Phase: Phase 2
• First received: December 5, 2012
• Last updated: February 6, 2017
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: August 2012
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Changli Wang, MD
• Phone: 86-022-23340123
• Email: wangchangli[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Icotinib of routine dose
Icotinib: 125mg, oral administration, three times per day.
• Icotinib of high dose
Icotinib: 375mg, oral administration, three times per day.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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