Actively Recruiting
Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer
Led by Copernicus Memorial Hospital · Updated on 2025-08-28
165
Participants Needed
2
Research Sites
300 weeks
Total Duration
On this page
Sponsors
C
Copernicus Memorial Hospital
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy of radiotherapy as part of the combined treatment approach for patients diagnosed with histopathologically confirmed small cell lung cancer (SCLC) in the advanced stage of extensive disease (ED) who are undergoing chemo-immunotherapy. The planned study aims to assess the impact of incorporating consolidative radiotherapy into the treatment strategy, focusing on residual changes following chemo-immunotherapy (during immunotherapy) and its effect on progression-free survival. This research experiment will be conducted as a randomized multi-center study, comprising the following treatment arms: * Arm I: Continuation of standard of care - PDL1/PD1 immunotherapy (durvalumab or atezolozumab) after chemo-immunotherapy based on platinum compounds; * Arm II: Standard of care, followed by consolidating radiotherapy of the chest area and possibly metastases (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each); * Arm III: Standard of care, followed by consolidating radiotherapy in the radical/ablative doses (total dose of 45 Gy delivered in 15 daily fractions of 3 Gy for the chest area, and total dose of 24 Gy in single fractions of 8 Gy administered every 2-3 days for the metastatic lesions) of the chest area and all metastatic lesions. Additionally, as part of routine weekly blood collections, an extra volume of 10 ml of blood will be collected. This additional blood sample will be obtained before starting radiotherapy, during each week of radiotherapy (maximum three collections), and at the time of disease progression (one collection), resulting in a total of five extra samples. The collected blood will be prepared, stored and used for circulating tumor DNA (ctDNA) testing, according to the protocol. The ctDNA analysis data will be utilized as a potential marker to determine the time to progression and assess the benefits derived from the administered radiotherapy.
CONDITIONS
Official Title
Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological confirmation of small cell lung cancer based on histological or cytological examination.
- Extensive stage of 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 or stable disease to platinum-based doublet chemotherapy with durvalumab or atezolizumab based on restaging imaging.
- Ability to undergo radiotherapy with doses of 45 Gy in 15 fractions to the chest and 24 Gy in single fractions every 2-3 days to metastatic lesions.
- Clinical control of brain metastases (prior whole-brain irradiation allowed).
- Measurable residual disease after chemioimmunotherapy or presence of tumor lesions not classified as measurable.
- Volume and number (up to 10) of metastatic lesions suitable for radiotherapy as per protocol.
- Absence of clinically significant and uncontrolled co-morbidities under pharmacological treatment.
- Absence of active autoimmune diseases except diabetes, hypothyroidism, psoriasis, eczema, lichen planus, and vitiligo.
- Adequate hematopoietic, renal, and hepatic function allowing treatment with atezolizumab or durvalumab according to current product guidelines.
You will not qualify if you...
- 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 by law based on Article 23A(1) of the Act on the Profession of Physician and Pharmacist.
- Presence of other uncontrolled malignant neoplasms.
- Contraindications to atezolizumab or durvalumab as specified in product guidelines.
- Grade 2 or higher pneumonitis from immunotherapy.
- Participation in another clinical trial during this study.
- Prior chest radiotherapy that prevents safe radiotherapy as per protocol; prior palliative radiotherapy to metastatic sites is allowed if clinically indicated.
- Contraindications to radiotherapy according to the approved protocol.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Center of Oncology of the Lublin Region St. Jana z Dukli in Lublin
Lublin, Poland
Actively Recruiting
2
Copernicus Memorial Hospital in Łódź
Lodz, Łódź Voivodeship, Poland, 93-513
Actively Recruiting
Research Team
Ł
Łukasz Kuncman, PhD
CONTACT
J
Jacek Fijuth, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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