Combining radiotherapy with immunotherapy for extensive small cell lung cancer
Official title: Lung Microcytoma Extensive Disease: Prospective Study of Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab
Run by Regina Elena Cancer Institute · NCT06771518 · Data updated 2026-11-12
This study is testing if combining radiation therapy with a type of immunotherapy can help people with extensive small cell lung cancer live longer after their initial treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 37 (estimated) |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | immunotherapy, atezolizumab, chemotherapy |
| Locations | 1 site (Rome, Rome) |
| Status | Recruiting |
| Started | December 15, 2021 |
| Main results expected | December 15, 2026 |
| Study ends | December 15, 2026 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT06771518 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a histological diagnosis of extensive-stage small cell lung cancer who have shown a partial response to initial treatment.
✕Probably not a fit
Patients with disease progression after chemo-immunotherapy or those who have previously received thoraco-mediastinal radiotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II clinical trial investigates the effectiveness of thoraco-mediastinal radiotherapy combined with maintenance immunotherapy using atezolizumab in patients with extensive-stage small cell lung cancer. The study aims to evaluate the impact of this combination on survival rates following chemotherapy. Patients will receive thoracic radiotherapy after showing a partial response to initial chemo-immunotherapy, with the goal of improving treatment outcomes. The trial will assess both the efficacy and tolerance of this treatment approach.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates for patients with extensive small cell lung cancer.
How similar studies have gone: While the combination of immunotherapy and chemotherapy has shown promise, the specific approach of adding radiotherapy in this context is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
"Regina Elena" National Cancer Institute
Rome, Rome, Italy Recruiting
Study contacts
- Study coordinator: Francesco Dionisi, Doctor
- Email: francesco.dionisi@ifo.gov.it
- Phone: 06-52663098
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.