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

Regina Elena Cancer Institute

Status and phase: Enrolling; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Drug: Atezolizumab 1200 mg e.v. q21; Radiation: Thoracic radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06771518

RS1620/21

Details and patient eligibility

About

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.

Full description

Prospective phase II study on patients affected by extensive-stage small cell lung cancer. The traditional treatment of lung microcytoma-extensive disease consists in platinum and etoposide-based chemotherapy. Radiotherapy of consolidation at the thoracic mediastinal level after chemotherapy may have an impact on survival and can be offered to patients in response to chemotherapy. Studies have recently shown that the addition of immunotherapy with atezolizumab to traditional chemotherapy improves survival compared to placebo. However, the use of consolidation radiotherapy was not permitted in the study thoracic level. Therefore the objective is to evaluate the efficacy and tolerance of the thoracic radiotherapy-immunotherapy association in the maintenance phase with atezolizumab of the treatment of lung microcytoma - extensive disease treated with chemo-immunotherapy.

Enrollment: 37 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological diagnosis of lung microcytoma;
• Age ≥18 years;
• Performance status according to ECOG 0-2;
• Extended disease at the time of first line oncological treatment;
• Initial staging and restaging after chemo-immunotherapy with CT, CT-PET FDG and brain MRI;
• In at least partial response (defined according to the Recist criteria [18]) after treatment chemoimmunotherapy according to the Impower 133 scheme;
• Haematological, respiratory toxicity ≤ G1, other toxicities ≤ G2 at the time of treatment radiotherapy;
• Pulmonary function tests at the time of radiotherapy treatment compatible with irradiation: FEV≥1.2 l or >40%, DLCO≥50%;
• Written informed consent.

Exclusion criteria

• Previous radiotherapy treatment at the thoraco-mediastinal level;
• In disease progression after chemo-immunotherapy treatment.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Thoracic radiotherapy-immunotherapy association in maintenance phase with atezolizumab

Experimental group

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.

Treatment:

Radiation: Thoracic radiotherapy

Drug: Atezolizumab 1200 mg e.v. q21