Evaluating radiotherapy in advanced small cell lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of incorporating radiotherapy into the treatment regimen for patients with advanced small cell lung cancer (SCLC) who are receiving chemo-immunotherapy. It is a randomized multi-center trial with two treatment arms: one continuing standard immunotherapy and the other adding consolidative radiotherapy to the chest and metastases. The focus is on evaluating progression-free survival and the impact of radiotherapy on residual disease following initial treatment. Patients will be monitored for their response to the combined treatment approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histopathological confirmation of small cell lung cancer based on histological or cytological examination.
* Primary clinical stage: Extensive stage of the disease according to VASLG classification or stage IV according to TNM classification.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 prior to randomization.
* Partial response (PR) or stable disease (SD) to platinum-based doublet chemotherapy with durvalumab or atezolizumab based on restaging (positron emission tomography \[PET\]/computed tomography \[CT\] or CT or magnetic resonance imaging \[MRI\]).
* Ability to undergo radiotherapy at a total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and a total dose of 24 Gy administered in single fractions every 2-3 days of 8 Gy to the metastatic lesions.
* Clinical control of brain metastases (prior whole-brain irradiation at any stage is acceptable before study entry).
* Measurable residual disease after chemioimmunotherapy (according to RECIST 1.1 solid tumor response assessment criteria) or in case of CR/PR presence of tumor lesions not classified as measurable.
* Volume and number (up to 10) of metastatic lesions allowing for radiotherapy in doses according to the study protocol.
* Absence of clinically significant and uncontrolled co-morbidities with pharmacological treatment.
* Absence of active autoimmune diseases except for diabetes, hypothyroidism, psoriasis, eczema, lichen planus, and vitiligo.
* Adequate hematopoietic function allowing treatment with atezolizumab or durvalumab, according to the current SmPC (Summary of Product Characteristics).
* Renal and hepatic function allowing treatment according to the current SmPC for atezolizumab or durvalumab.

Exclusion Criteria:

* Age under 18 years old.
* Premenopausal women who do not accept the need for effective contraception during radiotherapy and/or chemotherapy/immunotherapy.
* Individuals excluded from participation in a medical experiment based on Article 23A(1) of the Act on the Profession of Physician and Pharmacist.
* Coexistence of other uncontrolled malignant neoplasms.
* Contraindications to the use of atezolizumab or durvalumab as specified in the SmPC.
* Grade 2 or greater CTCAE v.5 pneumonitis secondary to immunotherapy.
* Participation in another clinical trial during the study.
* Prior chest radiotherapy that precludes safe administration of radiotherapy according to the study protocol. Prior palliative radiotherapy to metastatic sites is acceptable before study entry if clinically indicated as determined by the physician.
* Contraindications to radiotherapy according to the approved protocol.

Where it's running

• Center of Oncology of the Lublin Region St. Jana z Dukli in Lublin
  Lublin, Poland Recruiting
• Copernicus Memorial Hospital in Łódź
  Lodz, Łódź Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Łukasz Kuncman, PhD — Department of Radiotherapy, Copernicus Memoriał Hospital in Łódź, Poland
• Study coordinator: Łukasz Kuncman, PhD
• Email: lm.kuncman@kopernik.lodz.pl
• Phone: +4842 689 55 55

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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.