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New treatment option for Small Cell Lung Carcinoma
Official title Radiotherapy Strategies for Use in Combined Treatment of Small-cell Lung Cancer
ClinicalTrials.gov ID: NCT06529081
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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...
- Contraindications to radiotherapy according to the approved protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Lublin, Poland
- Lodz, Łódź Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lublin, Poland; Lodz, Łódź Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.