A Study of Erlotinib Plus Radiotherapy (RT) for Patients With Advanced or Inoperable Non-Small-Cell Lung Cancer

Study Summary

It is generally accepted that the presence of chronically hypoxic cells, or tumor cells which do not receive enough oxygen as a result of tumor growth, may be an important cause of resistance to radiation therapy (RT) and resultant tumor recurrence, particularly in large tumors such as advanced non-small-cell lung cancer (NSCLC). Therefore, delivering a higher RT dose, as is done with hypofractionated RT, to the tumor may result in higher success rate. Erlotinib (Tarceva, previously known as OSI-774) is an orally active, potent, selective inhibitor of the Epidermal Growth Factor Receptor (EGFR) tyrosine kinase. A recently completed trial has shown that Erlotinib as a single agent significantly improves the survival of patients with incurable Stage IIIb/IV NSCLC who have failed standard therapy for advanced or metastatic disease. Therefore, Erlotinib is an approved medication for second-line therapy in lung cancer following prior chemotherapy. This is a Phase II clinical research study to assess the efficacy and toxicity of hypofractionated radiation therapy in combination with Erlotinib in patients with locally advanced or inoperable non-small-cell lung cancer (NSCLC). The investigators' hypothesis is that the addition of erlotinib to RT will result in radiosensitization, therefore increasing the likelihood of local tumor control over RT alone. Maintenance erlotinib upon RT completion will result in further tumor growth inhibition, both systemically and locally, lengthening disease-free survival and overall survival.

Primary Outcome

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Interventions

• DRUG Erlotinib
• RADIATION Hypofractionated Radiotherapy