Clinical trial • Phase II • Oncology
Durvalumab for Extensive stage small cell lung cancer
Phase II trial of Durvalumab for Extensive stage small cell lung cancer. 43 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Extensive stage small cell lung cancer
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 16-10-2024
- First CTIS Authorization Date
- 29-10-2024
Trial design
Phase II trial across 10 sites in Germany.
- Target Sample Size
- 43
Eligibility
Recruits 43 No vulnerable population selected..
- Vulnerable Population
- No vulnerable population selected.
Inclusion criteria
- {"criterion_text":"-1.\tHistologically confirmed first diagnosis of ES-SCLC according to the Veterans Administration Lung Study Group (VALG) Staging System for SCLC."}
- {"criterion_text":"-Oligometastatic disease defined as follows: Primary tumor with or without mediastinal or supraclavicular lymph node metastases. Up to four distant tumor lesions/metastases that can be treated with stereotactic radiotherapy. No cytologically confirmed malignant pleural effusion."}
- {"criterion_text":"-Stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria after previous treatment with two cycles of platinum/etoposide/durvalumab."}
- {"criterion_text":"-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1."}
- {"criterion_text":"-Must have a life expectancy of at least 12 weeks."}
Exclusion criteria
- {"criterion_text":"-Prior systemic anticancer therapy (chemotherapy, immunotherapy, targeted therapy), apart from two cycles of etoposide/platinum + durvalumab"}
- {"criterion_text":"-Any unresolved toxicity NCI CTCAE Grade ≥2 from previous chemo-immunotherapy"}
- {"criterion_text":"-Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug"}
- {"criterion_text":"-Major surgical procedure within 28 days prior to the first dose of IP."}
- {"criterion_text":"-Active or prior documented autoimmune or inflammatory disorders"}
- {"criterion_text":"-Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab."}
- {"criterion_text":"-Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment."}
Endpoints
Primary endpoints
- {"endpoint_text":"-One-year progression-free survival (PFS) rate using investigator assessments according to RECIST 1.1","definition_or_measurement_approach":"Using investigator assessments according to RECIST 1.1"}
Recruitment
- Planned Sample Size
- 43
- Recruitment Window Months
- 23
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 43
Germany
- Earliest CTIS Part Ii Submission Date
- 10-09-2024
- Latest Decision Or Authorization Date
- 29-10-2024
- Processing Time Days
- 49
- Number Of Sites
- 10
- Number Of Participants
- 43
Sites
- Site Name
- Universitaet Des Saarlandes
- Department Name
- Klinik für Strahlentherapie und Radioonkologie
- Contact Person Name
- Markus Hecht
- Contact Person Email
- Markus.Hecht.Clinicaltrials@uks.eu
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- Klinik für Strahlentherapie
- Contact Person Name
- Klaus-Henning Kahl
- Contact Person Email
- KlausHenning.Kahl@uk-augsburg.de
- Site Name
- Johannes Gutenberg University Mainz
- Department Name
- Klinik und Poliklinik für Radioonkologie und Strahlentherapie
- Contact Person Name
- Marcus Stockinger
- Contact Person Email
- marcus.stockinger@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Strahlenklinik
- Contact Person Name
- Marlen Haderlein
- Contact Person Email
- Marlen.Haderlein@uk-erlangen.de
- Site Name
- Universitaetsklinikum Giessen und Marburg GmbH
- Department Name
- Klinik für Strahlentherapie
- Contact Person Name
- Daniel Habermehl
- Contact Person Email
- Daniel.Habermehl@uk-gm.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik und Poliklinik für Strahlentherapie
- Contact Person Name
- Felix Steger
- Contact Person Email
- f.steger@ukr.de
- Site Name
- Julius-Maximilians-Universitaet Wuerzburg
- Department Name
- Klinik und Poliklinik für Strahlentherapie
- Contact Person Name
- Philip Kleine
- Contact Person Email
- Kleine_P@ukw.de
- Site Name
- Rostock University Medical Center
- Department Name
- Klinik und Poliklinik für Strahlentherapie
- Contact Person Name
- Guido Hildebrandt
- Contact Person Email
- guido.hildebrandt@med.uni-rostock.de
- Site Name
- Krankenhaus Nordwest GmbH
- Department Name
- Klinik für Radioonkologie
- Contact Person Name
- Michael van Kampen
- Contact Person Email
- m.van_kampen@khnw.de
- Site Name
- Kliniken Maria Hilf GmbH Moenchengladbach
- Department Name
- Klinik für Strahlentherapie
- Contact Person Name
- Ursula Nestle
- Contact Person Email
- ursula.nestle@mariahilf.de
Sponsor
Primary sponsor
- Full Name
- Universitaet Des Saarlandes
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Third parties
- {"country":"Germany","full_name":"Interdisziplinaeres Zentrum Klinische Studien (IZKS)","duties_or_roles":"sponsorDuties code: 8","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- IMFINZI 50 mg/mL concentrate for solution for infusion.
- Active Substance
- Durvalumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Marketing authorisation: EU/1/18/1322/001
- Maximum Dose
- Max daily dose: 1500 mg; max total dose: 19500 mg
- Investigational Product Name
- Carbomedac 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Carboplatin
- Modality
- Small molecule
- Routes Of Administration
- Intravascular use
- Route
- Intravascular
- Authorisation Status
- Marketing authorisation: 39079.02.00
- Maximum Dose
- Max daily dose amount: 5 (unit: Other)
- Investigational Product Name
- Eto-GRY® 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Etoposide
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation: 45891.00.00
- Maximum Dose
- Max daily dose: 90 mg/m2; max total dose: 540 mg/m2
- Investigational Product Name
- Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
- Active Substance
- Cisplatin
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- Marketing authorisation: 39021.01.00
- Maximum Dose
- Max daily dose: 75 mg/m2; max total dose: 150 mg/m2
- Combination Treatment
- Yes
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