Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab

Arms (1)

1. type

   EXPERIMENTAL

   label

   Thoracic radiotherapy-immunotherapy association in maintenance phase with atezolizumab

   description

   Patients enrolled during the maintenance phase of chemoimmunotherapy treatment (standard of care) according to the IMPOWER 133 scheme which is divided as follows: 1) initial chemo-immunotherapy phase with IV treatment cycles with carboplatin AUC 5 day 1 and etoposide 100 mg/m2 days 1-3 q21 followed by a maintenance phase with immunotherapy (Atezolizumab day 1 1200 mg i.v. g1 of each cycle) until progression-toxicity. In association with immunotherapy, all patients will undergo treatment radiotherapy with 45 Gy in 15 fractions of 3 Gy administered 5 days a week on residual disease documented on CT-PET, dose 32.5Gy (2.16Gy for 15 fractions) on lymph node sites in response complete, equivalent to (EQD2 alpha beta 10) at 30 Gy in 3 fractions.

   interventionNames

   1. Radiation: Thoracic radiotherapy
   2. Drug: Atezolizumab 1200 mg e.v. q21

Primary outcomes (1)

1. measure

   Evaluate the efficacy of the association between radiotherapy and immunotherapy

   timeFrame

   60 months

   description

   The local recurrence rate of the disease at one year will be evaluated, with the aim of considering a % greater than 49.9% as unacceptable, assuming that with the experimental treatment object of this study a % of local recurrences of 30% can be achieved. We will therefore test the hypothesis of a local recurrence rate \>50% vs the hypothesis of a local control \<30%. Assuming a power of 80% and a one-sided significance level of 5%, it will be necessary to enroll 37 patients; if 13 or fewer local recurrences are observed, the study will be considered positive.