Clinical trial • Phase II • Oncology
ATEZOLIZUMAB for Large-cell neuroendocrine carcinoma of the lung
Phase II trial of ATEZOLIZUMAB for Large-cell neuroendocrine carcinoma of the lung.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Large-cell neuroendocrine carcinoma of the lung
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 09-10-2024
- First CTIS Authorization Date
- 24-10-2024
Trial design
open-label, no separate comparator arm; investigational treatment is atezolizumab in addition to standard of care chemotherapy (carboplatin or cisplatin plus etoposide). no distinct randomized comparator arm specified.-controlled Phase II trial across 15 sites in Germany.
- Open Label
- Yes
- Comparator
- No separate comparator arm; investigational treatment is Atezolizumab in addition to standard of care chemotherapy (Carboplatin or Cisplatin plus Etoposide). No distinct randomized comparator arm specified.
- Target Sample Size
- 67
Eligibility
Recruits 67 adults.
Inclusion criteria
- {"criterion_text":"- Written informed consent\n- Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without curative treatment options (patients with mixed histology are eligible if LCNEC is the predominant histology i.e. ≥50%)\n- Previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment)\n- Planned treatment with Carboplatin or Cisplatin and Etoposide (standard of care - SoC)\n- Eastern Cooperative Oncology Group (ECOG) performance status: 0-2\n- age ≥18 years\n- measurable disease according to RECIST v1.1\n- adequate organ function defined as: Alanine Aminotransferase (ALAT) / Aspartate Aminotransferase (ASAT) ≤2.5x ULN or ≤3.5x Upper limit of Normal (ULN) in case of liver metastases; Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases; Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60 ml/min; Neutrophils ≥1 Gigaparticle (Gpt)/l, Platelets >50 Gpt/l unless caused by bone marrow carcinosis"}
Exclusion criteria
- {"criterion_text":"- Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)\n- Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)\n- Severe uncontrolled infection\n- Prior treatment with either Atezolizumab or other immune checkpoint inhibitor\n- Any prior treatment for metastatic disease"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Overall Survival (OS, time to event endpoint, measured from cycle 1 day 1 (C1D1) to death from any cause)","definition_or_measurement_approach":"Overall Survival (OS), time to event endpoint, measured from cycle 1 day 1 (C1D1) to death from any cause"}
Secondary endpoints
- {"endpoint_text":"- Objective response rate (ORR) defined as partial remission (PR) or complete remission (CR) according to RECIST v1.1","definition_or_measurement_approach":"ORR defined as partial remission (PR) or complete remission (CR) according to RECIST v1.1"}
- {"endpoint_text":"- Immune ORR (iORR) defined as immune PR (iPR) or immune CR (iCR) according to iRECIST","definition_or_measurement_approach":"iORR defined as immune PR (iPR) or immune CR (iCR) according to iRECIST"}
- {"endpoint_text":"- Disease control rate (DCR) defined as combination of CR, PR and stable disease (SD) according to RECIST v1.1","definition_or_measurement_approach":"DCR defined as combination of CR, PR and stable disease (SD) according to RECIST v1.1"}
- {"endpoint_text":"- Progression free survival (PFS) defined as time from C1D1 to progression according to RECIST v1.1, or to start of any other anticancer treatment, or death from any cause whichever occurs first","definition_or_measurement_approach":"PFS defined as time from C1D1 to progression according to RECIST v1.1, or to start of any other anticancer treatment, or death from any cause whichever occurs first"}
- {"endpoint_text":"- Immune PFS (iPFS) defined as time from C1D1 to progression according to iRECIST or death from any cause whichever occurs first","definition_or_measurement_approach":"iPFS defined as time from C1D1 to progression according to iRECIST or death from any cause whichever occurs first"}
- {"endpoint_text":"- Duration of response (DoR) defined as time from first documented PR or CR according to RECIST v1.1 to time of disease progression according to RECIST v1.1 or death from any cause whichever occurs first","definition_or_measurement_approach":"DoR defined as time from first documented PR or CR according to RECIST v1.1 to time of disease progression according to RECIST v1.1 or death from any cause whichever occurs first"}
- {"endpoint_text":"- PFS/ iPFS (according to RECIST v1.1 and iRECIST) rate at 1 year","definition_or_measurement_approach":"PFS/iPFS rate at 1 year according to RECIST v1.1 and iRECIST"}
- {"endpoint_text":"- OS rate at 1 year","definition_or_measurement_approach":"Overall survival rate at 1 year"}
- {"endpoint_text":"- PFS, OS, DoR and ORR in central pathology confirmed cases of LCNEC","definition_or_measurement_approach":"Analysis of PFS, OS, DoR and ORR in cases centrally confirmed as LCNEC by pathology"}
- {"endpoint_text":"- Incidence, nature, severity of adverse events (grading according to NCI CTCAE (v5.0)","definition_or_measurement_approach":"Safety assessed by incidence, nature and severity of adverse events graded according to NCI CTCAE v5.0"}
Recruitment
- Planned Sample Size
- 67
- Recruitment Window Months
- 84
- Consent Approach
- Written informed consent is required from participants; no further details on assent, age-specific consent documents, or languages available are provided in the source.
Geography
- Total Number Of Sites
- 15
- Total Number Of Participants
- 67
Germany
- Earliest CTIS Part Ii Submission Date
- 16-10-2024
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 540
- Number Of Sites
- 15
- Number Of Participants
- 67
Sites
- Site Name
- Universitätsklinikum Frankfurt
- Department Name
- Studienzentrale Medizinische Klinik II, Hämatologie/Onkologie
- Principal Investigator Name
- Maximilian Rost
- Principal Investigator Email
- rost@med.uni-frankfurt.de
- Contact Person Name
- Maximilian Rost
- Contact Person Email
- rost@med.uni-frankfurt.de
- Site Name
- Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
- Department Name
- III. Med. Klinik und Poliklinik, Studienzentrale
- Principal Investigator Name
- Jürgen Alt
- Principal Investigator Email
- juergen.alt@unimedizin-mainz.de
- Contact Person Name
- Jürgen Alt
- Contact Person Email
- juergen.alt@unimedizin-mainz.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Dep. Thoracic Oncology/Internal Medicine
- Principal Investigator Name
- Farastuk Bozorgmehr
- Principal Investigator Email
- Farastuk.Bozorgmehr@med.uni-heidelberg.de
- Contact Person Name
- Farastuk Bozorgmehr
- Contact Person Email
- Farastuk.Bozorgmehr@med.uni-heidelberg.de
- Site Name
- Rems-Murr-Kliniken gGmbH
- Department Name
- Klinik für Hämatologie, Onkologie und Palliativmedizin
- Principal Investigator Name
- Heidrun Stumme
- Principal Investigator Email
- heidrun.stumme@rems-murr-kliniken.de
- Contact Person Name
- Heidrun Stumme
- Contact Person Email
- heidrun.stumme@rems-murr-kliniken.de
- Site Name
- Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
- Department Name
- des Deutschen Gemeinschafts-Diakonieverbandes GmbH
- Principal Investigator Name
- Monika Serke
- Principal Investigator Email
- monika.serke@lkhemer.de
- Contact Person Name
- Monika Serke
- Contact Person Email
- monika.serke@lkhemer.de
- Site Name
- LungenClinic Grosshansdorf GmbH
- Department Name
- LungenClinic Grosshansdorf GmbH
- Principal Investigator Name
- Martin Reck
- Principal Investigator Email
- m.reck@lungenclinic.de
- Contact Person Name
- Martin Reck
- Contact Person Email
- m.reck@lungenclinic.de
- Site Name
- Charité - Universitätsmedizin Berlin
- Department Name
- Centrum 12, Med. Klinik mit Schwerpunkt Infektiologie und Pneumologie, Campus Virchow-Klinikum
- Principal Investigator Name
- Nikolaj Frost
- Principal Investigator Email
- nikolaj.frost@charite.de
- Contact Person Name
- Nikolaj Frost
- Contact Person Email
- nikolaj.frost@charite.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Early Clinical Trial Unit
- Principal Investigator Name
- Martin Wermke
- Principal Investigator Email
- martin.wermke@ukdd.de
- Contact Person Name
- Martin Wermke
- Contact Person Email
- martin.wermke@ukdd.de
- Site Name
- Krankenhaus St. Elisabeth Und St. Barbara Halle (Saale) GmbH
- Department Name
- Medizinische Klinik III, Pneumologie/Hämatologie-Onkologie/Palliativmedizin
- Principal Investigator Name
- Bernhard Opitz
- Principal Investigator Email
- b.opitz@krankenhaus-halle-saale.de
- Contact Person Name
- Bernhard Opitz
- Contact Person Email
- b.opitz@krankenhaus-halle-saale.de
- Site Name
- Robert Bosch Krankenhaus GmbH
- Department Name
- Hämatologie, Onkologie und Palliativmedizin, RBK Lungenzentrum Stuttgart
- Principal Investigator Name
- Markus Wohlleber
- Principal Investigator Email
- markus.wohlleber@rbk.de
- Contact Person Name
- Markus Wohlleber
- Contact Person Email
- markus.wohlleber@rbk.de
- Site Name
- Lungenfachklinik Immenhausen
- Department Name
- Philippstiftung e.V.
- Principal Investigator Name
- Achim Rittmeyer
- Principal Investigator Email
- a.rittmeyer@lungenfachklinik-immenhausen.de
- Contact Person Name
- Achim Rittmeyer
- Contact Person Email
- a.rittmeyer@lungenfachklinik-immenhausen.de
- Site Name
- Pius-Hospital Oldenburg
- Department Name
- Klinik für Hämatologie und Onkologie, Cancer Center Oldenburg
- Principal Investigator Name
- Frank Griesinger
- Principal Investigator Email
- frank.griesinger@pius-hospital.de
- Contact Person Name
- Frank Griesinger
- Contact Person Email
- frank.griesinger@pius-hospital.de
- Site Name
- Asklepios Klinik Gauting GmbH
- Department Name
- Fachkliniken München-Gauting
- Principal Investigator Name
- Niels Reinmuth
- Principal Investigator Email
- n.reinmuth@asklepios.com
- Contact Person Name
- Niels Reinmuth
- Contact Person Email
- n.reinmuth@asklepios.com
- Site Name
- Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
- Department Name
- Klinik für Pneumologie
- Principal Investigator Name
- Christian Grohé
- Principal Investigator Email
- Christian.Grohe@jsd.de
- Contact Person Name
- Christian Grohé
- Contact Person Email
- Christian.Grohe@jsd.de
- Site Name
- Klinikum der Universität zu Köln
- Department Name
- Klinik I für Innere Medizin, Centrum für Integrierte Onkologie (CIO)
- Principal Investigator Name
- Jürgen Wolf
- Principal Investigator Email
- juergen.wolf@uk-koeln.de
- Contact Person Name
- Jürgen Wolf
- Contact Person Email
- juergen.wolf@uk-koeln.de
Sponsor
Primary sponsor
- Full Name
- Technische Universitaet Dresden
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Third parties
- {"country":"","full_name":"ROCHE Pharma AG","duties_or_roles":"Monetary support","organisation_type":""}
Investigational products
- Investigational Product Name
- Tecentriq 1 200 mg concentrate for solution for infusion
- Active Substance
- ATEZOLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- Marketing authorisation EU/1/17/1220/001
- Maximum Dose
- 42000 mg
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 20 (unit: Other)
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENIOUS INFUSION
- Route
- INTRAVENIOUS INFUSION
- Maximum Dose
- 320 mg/m2
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 1200 mg/m2
- Combination Treatment
- Yes
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