Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy

Phase 4

Suspended

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Icotinib

• Registration Number: NCT01720901
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.

Detailed Description

This single center, single arm open label study is designed to assess the safety and efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. The adverse events and adverse reaction are evaluated as well.

Study Timeline

• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Study Start: 2013-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC.
• Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors.
• Signed and dated informed consent before the start of specific protocol procedures.

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Exclusion Criteria

• Allergic to icotinib.
• Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib	Icotinib	Icotinib will be administered 250 mg one time by month, 3 times per day.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	4.5 months	Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.

Secondary Outcome Measures

Name	Time	Method
Overall survival	12 months	Overall survival is a duration from the date that first dose is given to the date of death.
Tumor response	6 weeks	Tumor response is designed by imaging according to Response Evaluation Criteria in Solid Tumors, including complete response, partial remission, stable disease as well as progressed disease.
Adverse Events	18 months	Adverse events will be coded in term of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.

Trial Locations

Locations (1)

Xiangya Hospital, Central-South Univercity; 🇨🇳 Changsha, Hunan, China