Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

Betta Pharmaceuticals

Status and phase: Unknown; Phase 2

Conditions: Non-small-cell Lung Cancer

Treatments: Drug: 2-year treatment with icotinib; Drug: 1-year treatment with icotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01929200

BD-IC-IV50

Details and patient eligibility

About

This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

Full description

Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patients signed the written informed consent
• The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation
• The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
• The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

Exclusion criteria

• Patients with unresected tumor
• Wild EGFR type
• Allergic to the study drug
• Patients have severe non-cancerous diseases
• Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

1-year treatment with icotinib

Experimental group

Description:

Patients will receive 1-year treatment with icotinib after operation.

Treatment:

Drug: 1-year treatment with icotinib

2-year treatment with icotinib

Experimental group

Description:

Patients will receive 2-year treatment with icotinib after operation.

Treatment:

Drug: 2-year treatment with icotinib