Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

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

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment37 (estimated)
SponsorRegina Elena Cancer Institute
Academic / other
Drugs / interventionsimmunotherapy, atezolizumab, chemotherapy
Locations1 site (Rome, Rome)
StatusRecruiting
StartedDecember 15, 2021
Main results expectedDecember 15, 2026
Study endsDecember 15, 2026
Registry record updatedJune 5, 2026
Trial IDNCT06771518 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.