Accelerated Hypofractionated or Conventionally Fractionated Radiotherapy and Durvalumab in Treating Patients With Stage II-III Non-small Cell Lung Cancer

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PRIMARY OBJECTIVE: I. To evaluate if the addition of MEDI4736 (durvalumab) to two schedules of radiation therapies (60 Gy in 30 fractions or 60 Gy in 15 fractions) is safe. SECONDARY OBJECTIVES: I. To examine if the addition of MEDI4736 (durvalumab) to radiation therapy is feasible. II. To assess to...

PRIMARY OBJECTIVE: I. To evaluate if the addition of MEDI4736 (durvalumab) to two schedules of radiation therapies (60 Gy in 30 fractions or 60 Gy in 15 fractions) is safe. SECONDARY OBJECTIVES: I. To examine if the addition of MEDI4736 (durvalumab) to radiation therapy is feasible. II. To assess toxicities associated with the addition of MEDI4736 (durvalumab) to radiation therapy. III. To obtain preliminary estimates of progression-free survival (PFS), using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, in patients who received MEDI4736 (durvalumab) added to radiation. EXPLORATORY OBJECTIVES: I. To assess the impact the addition of MEDI4736 (durvalumab) has on progression-free survival, using immune-related response criteria (irRC) guidelines. II. To assess the changes in circulating tumor cells (CTCs) and various immune parameters during treatment with durvalumab and radiotherapy and changes after completion of treatment. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 starting 2 weeks prior to radiation therapy. Treatment repeats every 4 weeks for 13 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiation therapy (ACRT) 1 fraction per day, 5 days per week for 15 fractions. ARM II: Patients receive durvalumab as in Arm I. Patients also undergo conventionally fractionated radiation therapy 1 fraction per day, 5 days per week for 30 fractions. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 4 months for 1 year.

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