Evaluating radiotherapy in advanced small cell lung cancer treatment
Assessment of Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer at the Stage of Extensive Disease - a Research Experiment
This study is testing if adding radiotherapy to the treatment of advanced small cell lung cancer can help patients live longer without their cancer getting worse while they are already receiving chemo-immunotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copernicus Memorial Hospital Academic / other |
| Drugs / interventions | durvalumab, atezolizumab, chemotherapy, immunotherapy, atezolozumab |
| Locations | 2 sites (Lublin and 1 other locations) |
| Trial ID | NCT06529081 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with histopathologically confirmed extensive stage small cell lung cancer who have shown a partial response or stable disease after initial chemotherapy.
Not a fit: Patients with early-stage small cell lung cancer or those who cannot tolerate radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve progression-free survival rates for patients with advanced small cell lung cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lublin and 1 other locations
- 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
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.