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Clinical Trial Finder

Search Results

A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung

Study Purpose

This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Written informed consent. 2. 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%) 3. 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) 4. Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC) 5. ECOG performance status: 0-2. 6. age ≥18 years. 7. measurable disease according to RECIST v1.1. 8. adequate organ function defined as: 1. ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases. 2. Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases. 3. Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60 ml/min. 4. Neutrophils ≥1 Gpt/l, Platelets >50 Gpt/l unless caused by bone marrow carcinosis.

Exclusion Criteria:

1. Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks) 2. Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment) 3. Severe uncontrolled infection. 4. Prior treatment with either Atezolizumab or other immune checkpoint inhibitor. 5. Any prior treatment for metastatic disease

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05470595
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Technische Universität Dresden
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Martin Wermke, MD
Principal Investigator Affiliation Technische Universität Dresden (TUD)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Active, not recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Large Cell Neuroendocrine Carcinoma of the Lung
Arms & Interventions

Arms

Experimental: Atezolizumab/Platinum/Etoposide

Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion.

Interventions

Drug: - Atezolizumab

Atezolizumab (IMP) will be added to Platinum/Etoposide (Standard-of-Care). Four cycles of combined immunochemotherapy 3qw will be follows by maintenance with atezolizumab monotherapy until progression.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Berlin, Germany

Status

Address

Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik

Berlin, , 10117

Evangelische Lungenklinik, Berlin, Germany

Status

Address

Evangelische Lungenklinik

Berlin, , 12125

Dresden, Germany

Status

Address

Universitätsklinikum Dresden, Medizinische Klinik 1

Dresden, , 01307

Frankfurt am Main, Germany

Status

Address

Klinikum der J.W. Goethe Universität, Medizinische Klinik II

Frankfurt am Main, , 60590

Asklepios Fachkliniken München-Gauting, Gauting, Germany

Status

Address

Asklepios Fachkliniken München-Gauting

Gauting, , 82131

LungenClinic Grosshansdorf GmbH, Großhansdorf, Germany

Status

Address

LungenClinic Grosshansdorf GmbH

Großhansdorf, , 22927

Halle (Saale), Germany

Status

Address

Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH

Halle (Saale), ,

Heidelberg, Germany

Status

Address

Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg

Heidelberg, , 69126

Hemer, Germany

Status

Address

Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH

Hemer, , 58675

Lungenfachklinik Immenhausen, Immenhausen, Germany

Status

Address

Lungenfachklinik Immenhausen

Immenhausen, , 34376

Köln, Germany

Status

Address

Klinikum der Universität zu Köln, Klinik I für Innere Medizin

Köln, , 50937

Mainz, Germany

Status

Address

Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik

Mainz, , 55131

Oldenburg, Germany

Status

Address

Pius Hospital, Klinik für Hämatologie und Onkologie

Oldenburg, , 26121

Robert-Bosch-Krankenhaus GmbH, Stuttgart, Germany

Status

Address

Robert-Bosch-Krankenhaus GmbH

Stuttgart, ,

Winnenden, Germany

Status

Address

Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin

Winnenden, , 71364

Resources

  • Patient and Caregiver Survey
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  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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