Icotinib in Advanced Non-small Cell Lung Cancer (NSCLC) With Hepatic Insufficiency

Betta Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: icotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02062515

BD-IC-IV51

Details and patient eligibility

About

The purpose of this study is to determine whether Icotinib is efficient and safe in treating advanced non-small cell lung cancer (NSCLC) patients with hepatic insufficiency.

Full description

Patients with hepatic insufficiency is an important subgroup of who receive EGFR TKIs. Phase I/II studies showed that Icotinib has good security. Based on the above considerations, this single-arm, open-label study is designed to evaluate the safety of icotinib 125mg three times daily for histologically or cytologically confirmed NSCLC patients with hepatic insufficiency.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed diagnosis of IIIB/IV stage NSCLC patients who are not suitable for surgery or radiotherapy
ECOG performance status points (PS) is 0-2
Liver function:

A (mild hepatic dysfunction):

A1) total bilirubin within normal limit (ULN), while AST> ULN;

A2) total bilirubin within1.0-1 .5 × ULN;

B (moderate hepatic dysfunction): total bilirubin within1.5-3 .0 × ULN

No malabsorption or other gastrointestinal disorders effecting drug absorption
Life expectancy: more than 12 weeks.

Exclusion criteria

Previous usage of HER/EGFR inhibitors or other target molecule drugs ( small molecule drugs or monoclonal antibody therapy )
Patients requires liver shunt , stent placement, or radiotherapy when 2 weeks before the start of the study or research process .
Patients with active hepatitis and cirrhosis.