Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer
NCT ID: NCT06529081
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
165 participants
INTERVENTIONAL
2024-04-01
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Treatment
PDL1/PD1 immunotherapy (durvalumab or atezolozumab - according to the SmPC) after chemo-immunotherapy based on platinum compounds.
No interventions assigned to this group
Standard Treatment with Palliative Radiotherapy
Palliative Radiotherapy
Standard treatment with added consolidative radiotherapy to the chest area and possibly metastatic lesions (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each).
Standard Treatment with Radical/Ablative Radiotherapy
Radical/Ablative Radiotherapy
Standard treatment with added radical/ablative radiotherapy (total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and total dose of 24 Gy administered in single fractions of 8 Gy every 2-3 days to the metastatic lesions) to the chest area and all metastatic lesions.
Interventions
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Palliative Radiotherapy
Standard treatment with added consolidative radiotherapy to the chest area and possibly metastatic lesions (if indicated) in doses and for palliative indications (total dose of 30 Gy in 10 daily doses of 3 Gy each).
Radical/Ablative Radiotherapy
Standard treatment with added radical/ablative radiotherapy (total dose of 45 Gy in 15 daily fractions of 3 Gy to the chest area and total dose of 24 Gy administered in single fractions of 8 Gy every 2-3 days to the metastatic lesions) to the chest area and all metastatic lesions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Medical Research Agency, Poland
OTHER_GOV
Copernicus Memorial Hospital
OTHER
Responsible Party
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Łukasz Kuncman
Principal Investigator
Principal Investigators
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Łukasz Kuncman, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Radiotherapy, Copernicus Memoriał Hospital in Łódź, Poland
Locations
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Center of Oncology of the Lublin Region St. Jana z Dukli in Lublin
Lublin, , Poland
Copernicus Memorial Hospital in Łódź
Lodz, Łódź Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20.
Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.
Slotman BJ, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Faivre-Finn C, Senan S. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 Jan 3;385(9962):36-42. doi: 10.1016/S0140-6736(14)61085-0. Epub 2014 Sep 14.
Goldman JW, Dvorkin M, Chen Y, Reinmuth N, Hotta K, Trukhin D, Statsenko G, Hochmair MJ, Ozguroglu M, Ji JH, Garassino MC, Voitko O, Poltoratskiy A, Ponce S, Verderame F, Havel L, Bondarenko I, Kazarnowicz A, Losonczy G, Conev NV, Armstrong J, Byrne N, Thiyagarajah P, Jiang H, Paz-Ares L; CASPIAN investigators. Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2021 Jan;22(1):51-65. doi: 10.1016/S1470-2045(20)30539-8. Epub 2020 Dec 4.
Gore EM, Hu C, Sun AY, Grimm DF, Ramalingam SS, Dunlap NE, Higgins KA, Werner-Wasik M, Allen AM, Iyengar P, Videtic GMM, Hales RK, McGarry RC, Urbanic JJ, Pu AT, Johnstone CA, Stieber VW, Paulus R, Bradley JD. Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extracranial Irradiation for Extensive-Disease Small Cell Lung Cancer (ED SCLC): NRG Oncology RTOG 0937. J Thorac Oncol. 2017 Oct;12(10):1561-1570. doi: 10.1016/j.jtho.2017.06.015. Epub 2017 Jun 23.
Timmerman R. A Story of Hypofractionation and the Table on the Wall. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):4-21. doi: 10.1016/j.ijrobp.2021.09.027. No abstract available.
Herbreteau G, Langlais A, Greillier L, Audigier-Valette C, Uwer L, Hureaux J, Moro-Sibilot D, Guisier F, Carmier D, Madelaine J, Otto J, Souquet PJ, Gounant V, Merle P, Molinier O, Renault A, Rabeau A, Morin F, Denis MG, Pujol JL. Circulating Tumor DNA as a Prognostic Determinant in Small Cell Lung Cancer Patients Receiving Atezolizumab. J Clin Med. 2020 Nov 27;9(12):3861. doi: 10.3390/jcm9123861.
Schoenfeld DA. Sample-size formula for the proportional-hazards regression model. Biometrics. 1983 Jun;39(2):499-503.
Kuncman L, Fijuth J, Tworek D, Sierko E, Cisek P, Maslowski M, Lisik-Habib M, Orzechowska M, Galwas-Kliber K, Antczak A, Chmielewska I, Ziolkowska B, Kurczewska-Michalak M, Kuznicki W, Jedrzejczak N, Ranoszek K, Bilski M. Radiotherapy(R) Integration(I) Strategy for Small(S)-Cell Lung Cancer in Extensive(E) Stage (RISE) with up to 10 metastases- a study protocol of a randomized phase II trial. BMC Cancer. 2025 Jan 24;25(1):142. doi: 10.1186/s12885-025-13552-y.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2023/ABM/01/00040
Identifier Type: -
Identifier Source: org_study_id
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