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

Betta Pharmaceuticals

Status and phase

Suspended

Phase 4

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Icotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01720901

BD-IC-IV41

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

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.