Icotinib in Advanced Metastatic Patients With NSCLC Previously Treated With Chemotherapy

Betta Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02486354

BD-IC-III01-V2

Details and patient eligibility

About

This study was a single-arm, multi-center, prospective, phase 3 trial aimed to evaluate the efficacy and safety of icotinib in patients with locally advanced or metastatic NSCLC after failure of at least one platinum-based chemotherapy regimen.

Enrollment: 128 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed locally advanced/metastatic (stage IIIB/stage IV, using the American Joint Committee on Cancer [AJCC] 6th edition of tumor-node-metastasis [TNM] staging system) NSCLC patients
• Progressed after at least one platinum-based chemotherapy regimen at entry
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• At least one measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.0
• Adequate hematologic and biochemical values

Exclusion criteria

• Patients with symptomatic brain metastases
• Malignant tumor within the previous five years
• Severe infection; congestive heart failure
• Previous treatment with drugs targeting EGFR
• History of interstitial lung disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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128 participants in 1 patient group

icotinib

Experimental group

Description:

Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.

Treatment:

Drug: icotinib