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

Safety Assessment of Icotinib in Advanced NSCLC Patients With Hepatic Insufficiency: A Multi-center, Open-label, Single-arm Study

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02062515

Enrollment

Registered

2014-02-13

Start date

2014-02-28

Completion date

2016-06-30

Last updated

2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

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.

Detailed 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.

Interventions

DRUGicotinib

Icotinib is administered orally 125 mg three times per day continuously for four weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events	Up to 4 weeks

Countries

China

Contacts

Primary ContactHao Long, MD

020-87343261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026