Atezolizumab After Concurrent Chemo-radiotherapy Versus Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer
NCT ID: NCT03540420
Last Updated: 2024-07-15
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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ACTIVE_NOT_RECRUITING
PHASE2
212 participants
INTERVENTIONAL
2018-07-31
2027-04-01
Brief Summary
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Detailed Description
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* completed 4 course of platinum/etoposide and thoracic radiotherapy of 45 Gy/30 fractions, 2 fractions per day
* non-progression after chemo-radiotherapy
* ECOG performance status 0-2
will be randomized to receive atezolizumab 1200 mg IV every 3 weeks in 12 months or standard of care (observation).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atezolizumab
atezolizumab after completed chemo-radiotherapy and non-progression
Atezolizumab
atezolizumab 1200 mg intravenous every 3 weeks in 12 months
Observation
standard care after completed chemo-radiotherapy and non-progression
No interventions assigned to this group
Interventions
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Atezolizumab
atezolizumab 1200 mg intravenous every 3 weeks in 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous radiotherapy to the thorax is allowed as long as the patient can receive TRT of 45 Gy.
* Stage I-III according to TNM v8 ineligible for surgery provided all lesions can be included in a tolerable radiotherapy field ("limited disease")
* ECOG performance status 0-2
* Measureable disease according to the RECIST 1.1
* Adequate organ function defined as: (a) Serum alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN); (b) Total serum bilirubin ≤ 1.5 x ULN; (c)Absolute neutrophil count (ANC) ≥ 1.5 x 10 superscr 9/L; (d) Platelets ≥ 100 x 10 superscr 9/L ; (e) Creatinine \< 100 µmol/L and calculated creatinine-clearance \> 50 ml/min. If calculated creatinine-clearance is \< 50 ml/min, an EDTA clearance should be performed
* No malignant cells in pericardial or pleural fluid (at least 1 sample should be obtained if pleural fluid is present) If there is so little fluid that it cannot easily be collected, the patient is considered eligible.
* Pulmonary function: FEV1 \> 1 l or \> 30 % of predicted value and DLCO \> 30 % of predicted value
* Female patients of childbearing potential (Postmenarcheal, not postmenopausal (\>12 continuous months of amenorrhea with no identified cause other than menopause), and no surgical sterilization) should use highly effective contraception and take active measures to avoid pregnancy while undergoing atezolizumab treatment and for at least 5 months after the last dose. Birth control methods considered to be highly effective are listed in Appendix D of the protocol
* Written informed consent
Exclusion Criteria
* serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator would compromise the patient's ability to complete the study, or would interfere with the evaluation of the efficacy and safety of the study treatment
* lung disease requiring systemic steroids in doses of \>10 mg prednisolone (or equivalent dose of other steroid)
* previous allogeneic or organ transplant
* active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
* history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
* live vaccine administered in the last 30 days
* active infection requiring IV antibiotics
* active viral hepatitis or HIV-positive
* conditions - medical, social, psychological - which could prevent adequate information and follow-up
* clinically active cancer other than SCLC with the exception of malignancies with a negligible risk of metastases or death (e.g. 5-years OS rate of \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. Hormonal therapy for non-metastatic prostate or breast cancer is allowed.
* pregnant or lactating women
18 Years
ALL
No
Sponsors
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University Hospital of North Norway
OTHER
Alesund Hospital
OTHER
Vestre Viken Hospital Trust
OTHER
University Hospital, Akershus
OTHER
Helse Nord-Trøndelag HF
OTHER
Helse Stavanger HF
OTHER_GOV
Haukeland University Hospital
OTHER
Sorlandet Hospital HF
OTHER_GOV
Ullevaal University Hospital
OTHER
Molde Hospital
OTHER
Helse Fonna
OTHER
Nordlandssykehuset HF
OTHER
Volda Hospital
OTHER
Kristiansund Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Skane University Hospital
OTHER
Karolinska University Hospital
OTHER
Ôrebro University Hospital
UNKNOWN
Gävle Hospital
OTHER
University Hospital, Linkoeping
OTHER
Odense University Hospital
OTHER
Aalborg University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
OTHER
Kantonsspital Winterthur KSW
OTHER
University Hospital, Basel, Switzerland
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Kantonsspital Graubünden
OTHER
Freiburger Spital
OTHER
Klinik Hirslanden, Zurich
OTHER
Kantonsspital Olten
OTHER
Spital STS AG
INDUSTRY
Ente Ospedaliero Cantonale, Bellinzona
OTHER
Cantonal Hospital of St. Gallen
OTHER
St. Olavs Hospital
OTHER
Oslo University Hospital
OTHER
Rijnstate Hospital
OTHER
Isala
OTHER
Zuyderland Medisch Centrum
OTHER
The Netherlands Cancer Institute
OTHER
St. Antonius Hospital
OTHER
Amphia Hospital
OTHER
Medisch Spectrum Twente
OTHER
Erasmus Medical Center
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Torstein B Rø, MD, PhD
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
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Aalborg Universitetshospital
Aalborg, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
National Cancer Institute
Vilnius, , Lithuania
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
Rijnstate Ziekenhuis
Arnhem, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Medische Centrum Twente
Enschede, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Zuyderland Ziekenhuis
Sittard, , Netherlands
Antonius Ziekenhuis
Utrecht, , Netherlands
Isala Ziekenhuis
Zwolle, , Netherlands
Ålesund Hospital
Ålesund, , Norway
Haukeland Universitetssykehus
Bergen, , Norway
Drammen sykehus - Vestre Viken
Drammen, , Norway
Haugesund hospital
Haugesund, , Norway
Sørlandet Sykehus
Kristiansand, , Norway
Sykehuset i Kristansund
Kristiansund, , Norway
Sykehuset Levanger
Levanger, , Norway
Molde Sjukehus
Molde, , Norway
Akershus Universitetssykehus AHUS
Oslo, , Norway
Oslo University Hospital Ullevål
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
Universitetssykehuset Nord-Norge
Tromsø, , Norway
Cancer Clinic at St. Olavs Hospital
Trondheim, , Norway
Volda hospital
Volda, , Norway
Gävle hospital
Gävle, , Sweden
Sahlgrenska Universitetssjukhus
Gothenburg, , Sweden
Universitetssjukhuset Linköping
Linköping, , Sweden
Skånes University Hospital
Lund, , Sweden
Universitetssjukhuset Örebro
Örebro, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Universitätsspital Basel
Basel, , Switzerland
Inselspital
Bern, , Switzerland
University Hospital Inselspital
Bern, , Switzerland
Kantonsspital Graubünden
Chur, , Switzerland
Kantonsspital Olten - Solothurner Spitäler
Olten, , Switzerland
Cantonal Hospital of St. Gallen
Sankt Gallen, , Switzerland
Spital STS AG
Thun, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Hirslanden Klinik
Zurich, , Switzerland
Countries
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Other Identifiers
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2017-004572-62
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2017-11-03BHG
Identifier Type: -
Identifier Source: org_study_id
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