Clinical trial • Phase II • Oncology
Atezolizumab for Small-cell lung cancer (limited disease)
Phase II trial of Atezolizumab for Small-cell lung cancer (limited disease).
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Small-cell lung cancer (limited disease)
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 29-08-2024
- First CTIS Authorization Date
- 11-10-2024
Trial design
Randomised, chemoradiotherapy alone (concurrent chemoradiotherapy) — comparator arm is chemoradiotherapy alone; no drug dose/schedule details for chemoradiotherapy provided in the provided data.-controlled Phase II trial across 25 sites in Denmark, Lithuania, Sweden and others.
- Randomised
- Yes
- Comparator
- Chemoradiotherapy alone (concurrent chemoradiotherapy) — comparator arm is chemoradiotherapy alone; no drug dose/schedule details for chemoradiotherapy provided in the provided data.
- Target Sample Size
- 215
Eligibility
Recruits 215 Vulnerable population not selected (isVulnerablePopulationSelected: false). Trial enrolment restricted to adults (Age ≥ 18 years). Written informed consent is required. Country-specific adult subject information and informed consent forms are provided (adult ICFs available for DK, LT, SE, NL, NO). No assent/parental consent procedures are indicated in the provided data..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected: false). Trial enrolment restricted to adults (Age ≥ 18 years). Written informed consent is required. Country-specific adult subject information and informed consent forms are provided (adult ICFs available for DK, LT, SE, NL, NO). No assent/parental consent procedures are indicated in the provided data.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years\n- Written informed consent\n- Histologically or cytologically confirmed small-cell lung cancer\n- Stage I-III according to TNM v8 ineligible for surgery provided all lesions can be included in a tolerable radiotherapy field (“limited disease”)\n- ECOG performance status 0-2\n- Measurable disease according to the RECIST 1.1. if the patient is enrolled before chemoradiotherapy commences.\n- Adequate kidney, liver and bone marrow function.\n- Pulmonary function: FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value. If there are reasons to believe that the lung function is reduced due to tumour obstruction of the lung or central airways, the patient is still eligible as long as a radiotherapist consider the patient eligible for thoracic radiotherapy."}
Exclusion criteria
- {"criterion_text":"- Malignant cells in pericardial or pleural fluid\n- Serious concomitant systemic disorders including disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid), previous allogeneic or organ transplant, autoimmune disease or immune deficiency, idiopathic pulmonary fibrosis, or pneumonitis\n- Live vaccine last 30 days, active infection requiring IV antibiotics, no active viral hepatitis or HIV\n- Clinically active cancer other than SCLC with the exception of malignancies with a negligible risk of metastases or death (i.e. 5-years OS rate of >90%)\n- History of severe allergic anaphylactic reactions to chimeric, human or humanized antibodies, or fusion proteins as well as known hypersensitivity to CHO cell products or any component of atezolizumab\n- Lung disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid)\n- Previous allogeneic or organ transplant\n- 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\n- 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"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Not specified in provided data (primary endpoint listed as Overall survival)."}
Secondary endpoints
- {"endpoint_text":"- Best response rates (best response observed through the whole study period)","definition_or_measurement_approach":"Not specified in provided data."}
- {"endpoint_text":"- Progression free survival","definition_or_measurement_approach":"Not specified in provided data."}
- {"endpoint_text":"- Toxicity","definition_or_measurement_approach":"Not specified in provided data."}
- {"endpoint_text":"- Health related quality of life","definition_or_measurement_approach":"Not specified in provided data."}
Recruitment
- Planned Sample Size
- 215
- Recruitment Window Months
- 293
- Consent Approach
- Written informed consent required from participants. Country-specific adult subject information and informed consent forms are available (documents labeled for adults for DK, LT, SE, NL, NO). Trial restricts enrollment to adults (Age ≥ 18), so no child assent/parental consent procedures are indicated in the provided data.
Geography
- Total Number Of Sites
- 25
- Total Number Of Participants
- 195
Denmark
- Earliest CTIS Part Ii Submission Date
- 20-09-2024
- Latest Decision Or Authorization Date
- 11-10-2024
- Processing Time Days
- 21
- Number Of Sites
- 3
- Number Of Participants
- 25
Sites
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Tine McCulloch
- Contact Person Email
- Tine.mcculloch@rn.dk
- Site Name
- Rigshospitalet
- Department Name
- Lung Cancer and Neuroendocrine Carcinoma Unit
- Contact Person Name
- Seppo Langer
- Contact Person Email
- Seppo.langer@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Tine Schytte
- Contact Person Email
- Tine.schytte@rsyd.dk
Lithuania
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 24-10-2024
- Processing Time Days
- 100
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Nacionalinis vezio institutas
- Department Name
- Department of Oncology
- Contact Person Name
- Saulius Cicenas
- Contact Person Email
- saulius.cicenas@nvi.lt
Sweden
- Earliest CTIS Part Ii Submission Date
- 23-09-2024
- Latest Decision Or Authorization Date
- 11-10-2024
- Processing Time Days
- 18
- Number Of Sites
- 6
- Number Of Participants
- 35
Sites
- Site Name
- Region Oerebro Laen
- Department Name
- Department of Oncology
- Contact Person Name
- Erik Lundin
- Contact Person Email
- Erik.lundin@orebroll.se
- Site Name
- Region Gaevleborg
- Department Name
- Department of Internal Medicine
- Contact Person Name
- Johan Isaksson
- Contact Person Email
- johan.isaksson@regiongavleborg.se
- Site Name
- Region Oestergoetland
- Department Name
- Department of Pulmonology
- Contact Person Name
- Anders Vikström
- Contact Person Email
- Anders.vikstrom@regionostergotland.se
- Site Name
- Lund University Hospital
- Department Name
- Department of Respiratory Medicine
- Contact Person Name
- Maria Planck
- Contact Person Email
- maria.planck@med.lu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Department of Head & Neck, Lung and Skin Cancer
- Contact Person Name
- Georgios Tsakonas
- Contact Person Email
- georgios.tsakonas@ki.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Department of Oncology
- Contact Person Name
- Jan Nyman
- Contact Person Email
- jan.nyman@oncology.gu.se
Netherlands
- Earliest CTIS Part Ii Submission Date
- 23-09-2024
- Latest Decision Or Authorization Date
- 11-10-2024
- Processing Time Days
- 18
- Number Of Sites
- 7
- Number Of Participants
- 48
Sites
- Site Name
- Netherlands Cancer Institute
- Department Name
- Department of Pulmonology
- Contact Person Name
- Willemijn Theelen
- Contact Person Email
- w.theelen@nki.nl
- Site Name
- Amphia Hospital
- Department Name
- Department of Pulmonology
- Contact Person Name
- K. H. van der Leest
- Contact Person Email
- LeestK@amphia.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Pulmanory Medicine Department
- Contact Person Name
- Niels Claessens
- Contact Person Email
- nclaessens@rijnstate.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Pulmanory Medicine Department
- Contact Person Name
- Joakim Aerts
- Contact Person Email
- j.aerts@erasmusmc.nl
- Site Name
- St. Antonius Ziekenhuis
- Department Name
- Department of Pulmonology
- Contact Person Name
- Lisanne Kastelijn
- Contact Person Email
- L.Kastelijn1@antoniusziekenhuis.nl
- Site Name
- Noordwest Ziekenhuisgroep Stichting
- Department Name
- Department of Oncology
- Contact Person Name
- Nicole Barlo
- Contact Person Email
- Nicole.Barlo@nwz.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Department of Pulmonology
- Contact Person Name
- Jos Stigt
- Contact Person Email
- j.a.stigt@isala.nl
Norway
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 13-10-2024
- Processing Time Days
- 89
- Number Of Sites
- 8
- Number Of Participants
- 83
Sites
- Site Name
- Helse Bergen HF
- Department Name
- Pulmanory Medicine Department
- Contact Person Name
- Marianne Aanerud
- Contact Person Email
- marianne.aanerud@helse-bergen.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Department of Oncology
- Contact Person Name
- Bjørn Henning Grønberg
- Contact Person Email
- bjorn.h.gronberg@ntnu.no
- Site Name
- Akershus University Hospital
- Department Name
- Pulmanory Medicine Department
- Contact Person Name
- Anne Siri Gløersen
- Contact Person Email
- afur@ahus.no
- Site Name
- Universitetssykehuset Nord-Norge HF
- Department Name
- Department of Oncology
- Contact Person Name
- Nina Helbekkmo
- Contact Person Email
- nina.helbekkmo@unn.no
- Site Name
- Helse Moere Og Romsdal HF
- Department Name
- Department of Medicine
- Contact Person Name
- Øyvind Yksnøy
- Contact Person Email
- Oyvind.Yksnoy@helse-mr.no
- Site Name
- Nord-Trondelag Hospital Trust
- Department Name
- Department of Pulmonology
- Contact Person Name
- Hanne Sorger
- Contact Person Email
- Hanne.Sorger@helse-nordtrondelag.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Department of Oncology
- Contact Person Name
- Maria Moksnes Bjaanæs
- Contact Person Email
- mamok@ous-hf.no
- Site Name
- Sorlandet Sykehus HF
- Department Name
- Department of Pulmonology
- Contact Person Name
- Guri Hoven
- Contact Person Email
- guri.hoven@sshf.no
Sponsor
Primary sponsor
- Full Name
- Norwegian University Of Science And Technolology
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Norway
Third parties
- {"country":"Netherlands","full_name":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Norway","full_name":"St. Olavs Hospital HF","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Lithuania","full_name":"Vilnius City Mental Health Center","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Sweden","full_name":"Sahlgrenska University Hospital-Vaestra Goetalandsregionen","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- Atezolizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/17/1220/001)
- Maximum Dose
- 1200 mg (maxDailyDoseAmount)
- Combination Treatment
- Yes
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