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Recruiting NCT06771518

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

Phase II Interventional Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thoracic radiotherapy, Atezolizumab 1200 mg e.v. q21.
Who it may be relevant to
Registry conditions: Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Lung Microcytoma Extensive Disease: Prospective Study of Association of Thoraco-mediastinal Radiotherapy With Maintenance Immunotherapy Treatment With Atezolizumab

Overview

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.

Detailed description

Prospective phase II study on patients affected by extensive-stage small cell lung cancer. The traditional treatment of lung microcytoma-extensive disease consists in platinum and etoposide-based chemotherapy. Radiotherapy of consolidation at the thoracic mediastinal level after chemotherapy may have an impact on survival and can be offered to patients in response to chemotherapy. Studies have recently shown that the addition of immunotherapy with atezolizumab to traditional chemotherapy improves survival compared to placebo. However, the use of consolidation radiotherapy was not permitted in the study thoracic level. Therefore the objective is to evaluate the efficacy and tolerance of the thoracic radiotherapy-immunotherapy association in the maintenance phase with atezolizumab of the treatment of lung microcytoma - extensive disease treated with chemo-immunotherapy.

Interventions

  • Radiation Thoracic radiotherapy
    Thoracic radiotherapy using 4D technique by irradiating the initial sites of disease (primary tumor and involved hilo-mediastinal lymph nodes). The treatments must be provided with the modulated intensity technique (IMRT or VMAT), treatments with conformal technique (3DCRT) are not permitted, where necessary, the Simultaneous Integrated Boost (SIB) technique can be used.
  • Drug Atezolizumab 1200 mg e.v. q21
    Radiotherapy treatment associated with Atezolizumab 1200 mg i.v. q21 administered according to clinical practice

Primary outcome measures

  • Evaluate the efficacy of the association between radiotherapy and immunotherapy [Time frame: 60 months]
Secondary outcome measures (1)
  • Measuring the tolerability [Time frame: 60 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • "Regina Elena" National Cancer Institute — Rome

Identifiers

NCT: NCT06771518 · RS1620/21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗