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

NCT06771518 | Recruiting Phase 2

• 1 other identifier: RS1620/21
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of the association between radiotherapy and immunotherapy

  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.

  60 months

Secondary Outcomes (1)

• Measuring the tolerability

  60 months

Study Arms (1)

Thoracic radiotherapy-immunotherapy association in maintenance phase with atezolizumab

EXPERIMENTAL

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.

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

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.

Thoracic radiotherapy-immunotherapy association in maintenance phase with atezolizumab

Atezolizumab 1200 mg e.v. q21 DRUG

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

Thoracic radiotherapy-immunotherapy association in maintenance phase with atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Francesco Dionisi, Doctor

CONTACT

06-52663098; francesco.dionisi@ifo.gov.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pharmacological interventional

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: January 13, 2025
• Study Start: December 15, 2021
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

IT (1)