Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab
Recruiting · NCT06771518 · Interventional (participants receive a specific treatment) · Lead sponsor: Regina Elena Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Atezolizumab 1200 mg e.v. q21Thoracic radiotherapy
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- "Regina Elena" National Cancer Institute - Rome, Rome, Italy