Randomized Phase III Trial of MEDI4736 (durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC
Objective
Primary Objectives The primary objective of this trial is to evaluate whether there is an improvement in overall survival with concomitant chemotherapy/radiation therapy/MEDI4736 (durvalumab) followed by one year (12 cycles) of MEDI4736 (durvalumab) as compared to concomitant chemotherapy/radiation followed by one year (12 cycles) of MEDI4736 (durvalumab).
Secondary Objectives Best objective response rate (ORR): To evaluate the difference in response using RECIST 1.1 criteria to assess whether or not MEDI4736 (durvalumab) added to concomitant chemo/radiation results in an improvement in response rates. Progression-free survival (PFS): To evaluate any difference in PFS with concomitant chemotherapy/radiation therapy/MEDI4736 (durvalumab) followed by one year (12 cycles) of MEDI4736 (durvalumab) as compared to concomitant chemotherapy/radiotherapy followed by one year of MEDI4736 (durvalumab). Recurrence patterns (RP) (local vs distant): To evaluate whether the incidence of recurrence and recurrence pattern is affected by giving MEDI4736 (durvalumab) during chemo/radiation. Local recurrence will be defined as any recurrence confined to the ipsilateral lung or the N1-N3 nodal areas. All other recurrences will be considered distal recurrences. Toxicity: To evaluate any difference in toxicity when MEDI4736 (durvalumab) is added to concomitant chemo/radiation using the CTCAE.
