Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer
NCT Number: NCT06529081
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Small Cell Lung Carcinoma
Interventions: RADIATION: Palliative Radiotherapy|RADIATION: Radical/Ablative Radiotherapy
Sponsor: Copernicus Memorial Hospital
Collaborators: Medical Research Agency, Poland
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 165
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-04-01
Completion Date: 2029-12-31
Locations: Copernicus Memorial Hospital in Łódź, Łódź, Łódzkie, 93-513, Poland

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) 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.

Primary Outcome Measures: Progression-free survival (PFS) according to RECIST 1.1 imaging criteria or patient death., The assessment of the impact of consolidative (radical/palliative) radiotherapy on residual post-chemoimmunotherapy (during immunotherapy) lesions on progression-free survival (PFS)., 12 months after last patient entry
Secondary Outcome Measures: Overall survival., At the end of the study (an average of 1 year after last patient entry).|Treatment toxicity (incidence of Grade 3 toxicity according to CTCAE v.5)., At the end of the study (an average of 1 year after last patient entry).|Site of progression (primary lesions [present at baseline]/new lesions)., At the end of the study (an average of 1 year after last patient entry).|Objective response rate (ORR)., At the end of the study (an average of 1 year after last patient entry).|Response rate in nonirradiated lesions., At the end of the study (an average of 1 year after last patient entry).