Chemo-immunotherapy Plus Thoracic Radiotherapy in Extensive Stage Small-cell Lung Cancer
NCT ID: NCT05223647
Last Updated: 2025-06-06
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
PHASE3
302 participants
INTERVENTIONAL
2022-01-11
2029-10-31
Brief Summary
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Detailed Description
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It is currently not possible to classify the patients who benefit from ICIs in SCLC. In this study, biological material (tissue, blood, feces) which will be analyzed for potential predictive and prognostic biomarkers.
Prophylactic cranial irradiation in ES SCLC is debated, mainly due to the potentially detrimental effect on cognition. Thus, frequency and timing of brain metastases and cognitive function will be assessed before, during and after study treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemo-immunotherapy plus thoracic radiotherapy
Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.
Thoracic radiotherapy of 30 Gy/10 fractions between 2nd and 3rd carboplatin/etoposide/durvalumab course.
Thoracic radiotherapy
30Gy/10 fractions thoracic radiotherapy given between 2nd and 3rd course of chemo-immunotherapy.
Chemo-immunotherapy
Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.
Chemo-immunotherapy
Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.
Chemo-immunotherapy
Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.
Interventions
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Thoracic radiotherapy
30Gy/10 fractions thoracic radiotherapy given between 2nd and 3rd course of chemo-immunotherapy.
Chemo-immunotherapy
Four courses of carboplatin/etoposide/durvalumab every 3 weeks followed by durvalumab every 4 weeks until intolerable toxicity, progressive disease leading to a need for other treatment, or until the patient no longer wishes to continue treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. ECOG performance status of 0 or 1
3. Body weight \>30 kg
4. Adequate bone marrow, liver and kidney function
5. Life expectancy of at least 3 months
6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 30 Gy/10 fractions
7. Histologically or cytologically confirmed SCLC
8. Stage III-IV disease (TNM v8)
9. FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
10. Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment
Exclusion Criteria
2. Major surgical procedure last 28 days
3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
4. Uncontrolled intercurrent illness
5. Other active malignancy
6. Leptomeningeal carcinomatosis
7. Immunosuppressive medication
8. Pregnant or breastfeeding women
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Haukeland University Hospital
OTHER
University Hospital of North Norway
OTHER
Alesund Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
Oslo University Hospital
OTHER
Helse Nord-Trøndelag HF
OTHER
Helse Fonna
OTHER
Drammen sykehus
OTHER
University Hospital, Akershus
OTHER
Erasmus Medical Center
OTHER
Sahlgrenska University Hospital
OTHER
Karolinska University Hospital
OTHER
Gävle Hospital
OTHER
Sykehuset Innlandet HF
OTHER
North Estonia Medical Centre
OTHER
Nordlandssykehuset HF
OTHER
Landspitali University Hospital
OTHER
Lund University Hospital
OTHER
University Hospital, Linkoeping
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Magnus Steigedal, PhD
Role: STUDY_DIRECTOR
Department of Clinical and Molecular Medicine, NTNU
Locations
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North Estonia Medical Centre
Tallinn, , Estonia
Landspitali University Hospital
Reykjavik, , Iceland
Erasmus MC
Rotterdam, , Netherlands
Ålesund Hospital
Ålesund, , Norway
Haukeland Universitetssykehus
Bergen, , Norway
Nordlandssykehuset HF
Bodø, , Norway
Drammen sykehus - Vestre Viken
Drammen, , Norway
Innlandet hospital Gjøvik
Gjøvik, , Norway
Haugesund hospital
Haugesund, , Norway
Sykehuset Levanger
Levanger, , Norway
Akershus Universitetssykehus AHUS
Oslo, , Norway
Oslo University Hospital Ullevål
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
University Hospital of North Norway, Pulmonology Department
Tromsø, , Norway
Cancer Clinic at St. Olavs Hospital
Trondheim, , Norway
Gävle hospital
Gävle, , Sweden
Sahlgrenska Sjukehuset
Gothenburg, , Sweden
Linköping University Hospital
Linköping, , Sweden
Lund University Hospital
Skåne, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Kersti Oselin
Role: primary
Örvar Gunnarsson
Role: primary
Joachim Aerts
Role: primary
Øyvind Yksnøy
Role: primary
Marianne Aanerud
Role: primary
Luka Stanisavljevic, MD
Role: primary
Odd Terje Brustugun
Role: primary
Daniel Heinrich
Role: primary
Sverre Fluge
Role: primary
Hanne Sorger
Role: primary
Kirill Neumann
Role: primary
Maria Moksnes Bjaanes
Role: primary
Madebo Tesfaye
Role: primary
Nina Helbekkmo
Role: primary
Bjørn H Grønberg
Role: primary
Johan Isaksson
Role: primary
Jan Nyman
Role: primary
Anders Vikström
Role: primary
Emelie Gezelius
Role: primary
Georgios Tsakonas
Role: primary
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2020203
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
EC#230766
Identifier Type: -
Identifier Source: org_study_id
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