Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Clinical Trial
Official title:
A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC)
This randomized phase II trial studies how well erlotinib hydrochloride or crizotinib with chemoradiation therapy works in treating patients with stage III non-small cell lung cancer. Radiation therapy uses high energy x rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin, etoposide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving erlotinib hydrochloride is more effective than crizotinib with chemoradiation therapy in treating patients with non-small cell lung cancer.
PRIMARY OBJECTIVES:
I. To assess whether patients with unresectable local-regionally advanced non-small cell lung
cancer (NSCLC) treated with targeted agents based on molecular characteristics have a longer
progression-free survival than those treated with standard care therapy alone.
SECONDARY OBJECTIVES:
I. To evaluate response rate. II. To assess toxicity. III. To assess overall survival. IV. To
correlate clinical outcomes with tumor molecular aberrations identified from deep sequencing
of selected kinomes in patients from whom adequate baseline tissue is available.
OUTLINE: Eligible patients are assigned to one of two cohorts based on pre-enrollment
screening by the enrolling institution for two biomarkers: EGFR TK mutation and EML4-ALK
fusion arrangement. Within each cohort, patients are randomized to either an experimental or
control arm, resulting in a total of four treatment arms overall. Patients with both the EGFR
mutation and ALK arrangement are placed in the ALK Cohort.
Planned Sample Size: 156 for the EGFR mutation cohort and 78 for the ALK translocation cohort
After completion of study treatment, patients are followed at 1 and 2 months, 4-6 weeks,
every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
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