Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06771518

Study of Thoraco-mediastinal Radiotherapy Combined With Maintenance Immunotherapy Using Atezolizumab in Patients With Extensive-Stage Small Cell Lung Cancer

Led by Regina Elena Cancer Institute · Updated on 2025-01-13

37

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with extensive-stage small cell lung cancer to evaluate the role of thoraco-mediastinal consolidative radiotherapy combined with maintenance immunotherapy using atezolizumab. This phase II study aims to assess the effectiveness and tolerance of adding thoracic radiotherapy after chemo-immunotherapy treatment, which includes atezolizumab, for patients with this type of lung cancer. The study builds on previous findings that adding atezolizumab to chemotherapy improves survival but extends investigation into the impact of combining radiotherapy in the maintenance phase. Participants will receive thoracic radiotherapy targeting the initial disease sites using advanced techniques like IMRT or VMAT, with possible use of the Simultaneous Integrated Boost (SIB) technique. This radiation treatment is provided alongside maintenance immunotherapy with intravenous atezolizumab dosed at 1200 mg every 21 days, following clinical practice guidelines. Radiotherapy must be delivered with modulated intensity, and conformal technique is not allowed. Throughout the study, participants will undergo imaging assessments including CT, CT-PET FDG, and brain MRI for staging and restaging. Researchers will monitor treatment response, toxicities, pulmonary function tests, and overall safety during radiotherapy and immunotherapy. The primary measure is to evaluate the combined treatment's effectiveness over 60 months. Participants must provide informed consent and meet specific health and lung function criteria before enrollment.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological diagnosis of lung microcytoma
  • Age 18 years or older
  • Performance status according to ECOG 0-2
  • Extensive disease at the time of first line oncological treatment
  • Initial staging and restaging after chemo-immunotherapy with CT, CT-PET FDG, and brain MRI
  • At least partial response after chemo-immunotherapy according to the Impower 133 scheme
  • Haematological and respiratory toxicity less than or equal to grade 1, other toxicities less than or equal to grade 2 at the time of radiotherapy
  • Pulmonary function tests compatible with irradiation: FEV ≥1.2 l or >40%, DLCO ≥50%
  • Written informed consent
Not Eligible

You will not qualify if you...

  • Previous radiotherapy treatment at the thoraco-mediastinal level
  • Disease progression after chemo-immunotherapy treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

"Regina Elena" National Cancer Institute

Rome, Italy, 00144

Actively Recruiting

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Research Team

F

Francesco Dionisi, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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