High Dose Icotinib in Advanced Non-small Cell Lung Cancer With EGFR 21 Exon Mutation (INCREASE)

Betta Pharmaceuticals

Status and phase: Unknown; Phase 4

Conditions: NSCLC

Treatments: Drug: icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02404675

AKTN-NSCLC-01

Details and patient eligibility

About

This randomized, open-label study is aimed to evaluate the efficacy of high-dose icotinib in treating advanced non-small cell lung cancer patients with positive EGFR 21 exon mutation.

Enrollment: 240 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)
• Positive EGFR 21 exon mutation or 19 exon deletion
• Age 18-75 years old with performance status of 0 to 2
• With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria
• Adequate hematological, biochemical and organ functions.

Exclusion criteria

• Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
• Evidence of interstitial lung diseases
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 3 patient groups

21 icotinib (250mg)

Experimental group

Description:

Patients with EGFR 21 exon positive are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 250 mg three times per day, till progressive disease or unaccepted toxicity.

Treatment:

Drug: icotinib

21 icotinib (125mg)

Active Comparator group

Description:

Patients with EGFR 21 exon positive are randomly assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity

Treatment:

Drug: icotinib

19 icotinib (125mg)

Experimental group

Description:

Patients with EGFR del 19 exon positive are assigned to routine dose icotinib group to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity

Treatment:

Drug: icotinib