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

NCT ID: NCT06771518

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2026-12-15

Brief Summary

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.

Detailed 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.

Conditions

Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Thoracic radiotherapy

Intervention Type: 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

Intervention Type: DRUG

Radiotherapy treatment associated with Atezolizumab 1200 mg i.v. q21 administered according to clinical practice

Interventions

Thoracic radiotherapy

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.

Intervention Type: RADIATION

Atezolizumab 1200 mg e.v. q21

Radiotherapy treatment associated with Atezolizumab 1200 mg i.v. q21 administered according to clinical practice

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regina Elena Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

"Regina Elena" National Cancer Institute

Rome, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Dionisi, Doctor

Role: CONTACT

francesco.dionisi@ifo.gov.it

06-52663098

Facility Contacts

Francesco Dionisi, Doctor

Role: primary

francesco.dionisi@ifo.gov.it

06-52663098

Other Identifiers

RS1620/21

Identifier Type: -

Identifier Source: org_study_id