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Protocol Summary


Protocol No.
PSCI-21-041
Prinicipal Investigator
Ma, Patrick
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
EA5181
Title
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.
Applicable Disease Sites
Lung
Status
Open
Participating Institutions
Hershey Medical Center