High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease

Betta Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Routine dose icotinib; Drug: Higher dose icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02027090

BD-IC-IV17

Details and patient eligibility

About

We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology);
• Pretreated with at least 1 platinum-based chemotherapy;
• No previous targeted treatment such as gefitinib, erlotinib;
• With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria;
• WHO performance status(PS)<= 2;
• Adequate organ functions;
• Signed and dated informed consent before the start of specific protocol procedures.

Exclusion criteria

• Allergic to icotinib;
• Patients with metastatic brain tumors with symptoms;
• Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab;
• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Higher dose icotinib

Experimental group

Description:

Patients with stable disease after 8-week routine dose icotinib treatment, are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 375 mg three times per day, till progressive disease or unaccepted toxicity.

Treatment:

Drug: Higher dose icotinib

Routine dose icotinib

Active Comparator group

Description:

Patients with stable disease after 8-week routine dose icotinib treatment, are administered with icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity.

Treatment:

Drug: Routine dose icotinib