Icotinib Versus Placebo as Adjuvant Therapy in EGFR-mutant Lung Adenocarcinoma (ICWIP)

Betta Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma

Treatments: Drug: Icotinib; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02125240

BD-IC-IV-59

Details and patient eligibility

About

The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Full description

This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Primary Outcome Measure:

Disease-free survival between Icotinib group and placebo group.

Secondary Outcome Measures:

Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed lung adenocarcinoma after surgical resection
• Stage II-IIIA disease according to 7th edition of TNM staging
• Patients must harbor sensitive EGFR gene mutation (19/21)
• Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy

Exclusion criteria

• Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
• Presence of metastatic disease
• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
• Any unresolved chronic toxicity from previous anticancer therapy
• Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups

Icotinib

Experimental group

Description:

125 mg three times daily (375 mg per day) by mouth

Treatment:

Drug: Icotinib

Placebo

Active Comparator group

Description:

1 tablet three times daily by mouth

Treatment:

Drug: Placebo