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Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer


Title RTOG 1306: A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC)
Therapeutic Area Lung Cancer
Principal Investigator Kathryn Huber, MD PhD
Min Age 18 Years
Gender Both
Contact Fadi Obeid
617-636-7651
More Information https://clinicaltrials.gov/ct2/show/NCT01822496

Overview

Cancer is a disease caused by alterations in the functions of genes within the cells. In approximately 15% of patients with non-small cell lung cancer, one of two genes is altered significantly (known as EGFR mutation or ALK rearrangement). Erlotinib, a pill, taken on a daily basis produces significant decrease in the size of tumors in patients with advanced stage lung cancer with EGFR mutation. Similarly, another pill, crizotinib, produces significant decrease in the size of tumors in patients with advanced stage lung cancer with ALK rearrangement. However it is not clear how useful these two drugs will be in patients with a less advanced form of lung cancer in the presence of these gene alterations.  The purpose of this study is to find out what effects, good and/or bad, one of the following treatments has on locally advanced, non-operable lung cancer with specific gene alterations (EGFR mutation or ALK rearrangement).

Study Details

Inclusion Criteria

  • Newly diagnosed, unresectable, stage III, non-squamous, non-small cell lung cancer
  • Otherwise normal organ function

Exclusion Criteria

  • No pregnant or nursing women
  • No prior therapy for the newly diagnosed cancer
  • No complicating diseases or malignancies such as Chronic Obstructive Pulmonary Disease or an allergy to the study drugs

Study Requirements

On the experimental arms, subjects will take oral chemotherapy daily for 12 weeks, and visit the hospital for a clinic visit every 3 weeks and a CT scan every 6 weeks during that time. All subjects will have chemoradiation. During chemoradiation, subjects will come to the hospital for radiation 5 days per week for 6 weeks and have clinic visits every 3 weeks during that time. After chemoradiation, subjects will come to the hospital for follow up visits 1 month and 2 months after the end of chemoradiation and then every 3 months for 2 years, then every 5 months for 3 years, and then annually thereafter.