Combining radiotherapy with immunotherapy for extensive small cell lung cancer
Lung Microcytoma Extensive Disease: Prospective Study of Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab
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 |
| Enrollment | 37 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Drugs / interventions | immunotherapy, atezolizumab, chemotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT06771518 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco Dionisi, Doctor
- Email: francesco.dionisi@ifo.gov.it
- Phone: 06-52663098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.