Study on Afatinib with Chemotherapy and Radiation for EGFR-Mutant Non-Small Cell Lung Cancer

Program Overview

This study is exploring the effectiveness of adding Afatinib, a type of drug known as a tyrosine kinase inhibitor, to the standard treatment of chemotherapy and radiation for patients with stage III non-small cell lung cancer (NSCLC) that has mutations in the epidermal growth factor receptor (EGFR). Afatinib is given before and after the standard treatment to see if it can help shrink the tumor and improve the overall response to treatment. The study aims to determine if this approach can enhance the effectiveness of the standard treatment.

Description

The study treatment is divided into five stages:

1. Induction Stage: Patients will take Afatinib, a pill, once a day for two 4-week cycles. They will keep a diary to record their doses.

2. Concurrent Stage: Patients will receive radiation therapy and chemotherapy with cisplatin and pemetrexed for two 3-week cycles.

3. Surgery Stage: If possible, surgery will be performed to remove the tumor about 4-6 weeks after finishing radiation and chemotherapy. The timing depends on recovery from treatment side effects. A piece of the removed tumor will be used for research to find markers that may predict response to treatment.

4. Adjuvant Chemotherapy Stage: After surgery, patients may receive additional chemotherapy, starting 6-12 weeks after surgery or after finishing radiation if surgery is not performed. This decision is made by the patient's doctor.

5. Consolidation Stage: Patients who responded to the initial Afatinib treatment will continue taking it for twenty-six 4-week cycles (2 years).

Patients will be monitored for up to 5 years after stopping treatment to assess long-term effects. CT scans will be conducted every 3 months for the first year, every 6 months for years 2-4, and once in year 5.

Eligibility Criteria

Locations