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Randomized Phase III Trial of MEDI4736 (Durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC
This phase III trial studies how well an antibody (durvalumab) with chemotherapy and radiation therapy (chemoradiation) works in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery (unresectable).
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.
Chemotherapy (NOS); Immunotherapy; Radiotherapy
AMP-514 (Durvalumab); Alimta (Pemetrexed); Durvalumab (); MEDI4736 (Durvalumab); Paraplatin (carboplatin); Pemetrexed (); Radiotherapy (); Taxol (paclitaxel); carboplatin (); cisplatin (); etoposide (); paclitaxel ()
Inclusion Criteria: STEP 1 INCLUSION CRITERIA
Exclusion Criteria: STEP 1 EXCLUSION ELIGIBILITY CRITERIA - CONCURRENT THERAPY
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