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

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Icotinib of high dose; Drug: Icotinib of routine dose

• Registration Number: NCT01744925
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-08
• Study Start: 2012-10
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-05
• Study First Posted: 2012-12-07
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-07
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Icotinib of high dose	Icotinib of high dose	Icotinib: 375mg, oral administration, three times per day.
Icotinib of routine dose	Icotinib of routine dose	Icotinib: 125mg, oral administration, three times per day.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Progression free survival	3 months	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.
Overall survival	14 months	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.
Number of Participants with Adverse Events	18 months	Adverse events, Serious adverse events , incidence of and reason for study drug dose interruptions and discontinuations, laboratory assessments, vital signs.

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China