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

Sponsor
Regina Elena Cancer Institute
Study ID
NCT06771518
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Thoracic radiotherapy — RADIATION
    Thoracic radiotherapy using 4D technique by irradiating the initial sites of disease (primary tumor and involved hilo-mediastinal lymph nodes). The treatments must be provided with the modulated intensity technique (IMRT or VMAT), treatments with conformal technique (3DCRT) are not permitted, where necessary, the Simultaneous Integrated Boost (SIB) technique can be used.
  • Atezolizumab 1200 mg e.v. q21 — DRUG
    Radiotherapy treatment associated with Atezolizumab 1200 mg i.v. q21 administered according to clinical practice

Study Details

Investigate the role of consolidative radiotherapy treatment at the thoraco-mediastinal level in the patient suffering from lung microcytoma - extensive disease and treated with chemo-immunotherapy with atezolizumab, in association with maintenance therapy with atezolizumab.

Key Dates

Start date
Dec 15, 2021
Status verified
Jun 2026
Primary completion
Dec 15, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Thoracic radiotherapy-immunotherapy association in maintenance phase with atezolizumab
    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.

Primary Outcome Measure

Evaluate the efficacy of the association between radiotherapy and immunotherapy [ Time Frame: 60 months ]

Central Contacts

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