Status:
RECRUITING
Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer
Lead Sponsor:
Copernicus Memorial Hospital
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06529081
Start Date
April 1 2024
End Date
December 31 2029
Last Update
August 28 2025
Active Locations (2)
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1
Center of Oncology of the Lublin Region St. Jana z Dukli in Lublin
Lublin, Poland
2
Copernicus Memorial Hospital in Łódź
Lodz, Łódź Voivodeship, Poland, 93-513