Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-30 @ 12:36 AM
Study NCT ID:
NCT05470595
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-20
First Post:
2022-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 67}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2029-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2022-07-13', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Secondary efficacy endpoints in defined molecular subtypes (NSCLC-type / SCLC-type)', 'timeFrame': 'appr. 72 months'}, {'measure': 'Quality of Life assessed by EORTC QLQ-C30.', 'timeFrame': 'appr. 72 months'}, {'measure': 'Quality of Life assessed by EORTC QLQ-LC13.', 'timeFrame': 'appr. 72 months'}, {'measure': 'Immune Effectors', 'timeFrame': 'appr. 72 months', 'description': 'Changes in cellular and humoral immune effectors in peripheral blood and their correlation with response.'}, {'measure': 'Mutational Landscape', 'timeFrame': 'appr. 72 months', 'description': 'Mutational landscape of LCNEC in comparison to SCLC as well as squamous and Adenocarcinoma of the lung. The analysis will be using whole genome sequencing.'}, {'measure': 'Tumor DNA (tDNA) level', 'timeFrame': 'appr. 72 months', 'description': 'Dynamics of circulating tumor DNA levels (changes from baseline).'}, {'measure': 'Therapy Resistance', 'timeFrame': 'appr. 72 months', 'description': 'Mechanisms of therapy resistance (changes of immune invasion and mutational landscape in tumor re-biopsy upon progression).'}], 'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'appr. 72 months', 'description': 'To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC as measured by overall survival.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'appr. 72 months', 'description': 'According to RECIST v1.1 as assessed by local investigator.'}, {'measure': 'Immune Objective Response Rate (iORR)', 'timeFrame': 'appr. 72 months', 'description': 'According to iRECIST as assessed by local investigator.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'appr. 72 months', 'description': 'According to RECIST v1.1 as assessed by local investigator.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'appr. 72 months'}, {'measure': 'Immune Progression Free Survival (iPFS)', 'timeFrame': 'appr. 72 months'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'appr. 72 months'}, {'measure': 'Progression Free Survival (PFS) rate at one year', 'timeFrame': '1 year'}, {'measure': 'Immune Progression Free Survival (iPFS) rate at one year', 'timeFrame': '1 year'}, {'measure': 'Overall survival at one year', 'timeFrame': '1 year'}, {'measure': 'Incidence, intensity, seriousness, relationship to Atezolizumab, and outcome of adverse events graded according to NCI CTCAE (v5.0).', 'timeFrame': 'appr. 72 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Cancer', 'LCNEC', 'Neuroendocrine Carcinoma'], 'conditions': ['Large Cell Neuroendocrine Carcinoma of the Lung']}, 'descriptionModule': {'briefSummary': 'This phase II clinical trial evaluates the efficacy, safety and tolerability of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent\n2. 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%)\n3. 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)\n4. Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC)\n5. ECOG performance status: 0-2\n6. age ≥18 years\n7. measurable disease according to RECIST v1.1\n8. adequate organ function defined as:\n\n 1. ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases\n 2. Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases\n 3. Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault \\>60 ml/min\n 4. Neutrophils ≥1 Gpt/l, Platelets \\>50 Gpt/l unless caused by bone marrow carcinosis\n\nExclusion Criteria:\n\n1. Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)\n2. Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)\n3. Severe uncontrolled infection\n4. Prior treatment with either Atezolizumab or other immune checkpoint inhibitor\n5. Any prior treatment for metastatic disease'}, 'identificationModule': {'nctId': 'NCT05470595', 'acronym': 'LCNEC-ALPINE', 'briefTitle': 'A Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'A Phase II, Single-arm Trial of Atezolizumab/Platinum/Etoposide for the Treatment of Advanced Large-cell Neuroendocrine Cancer of the Lung', 'orgStudyIdInfo': {'id': 'TUD-ALPINE-077'}, 'secondaryIdInfos': [{'id': '2020-002683-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atezolizumab/Platinum/Etoposide', 'description': 'Atezolizumab/Platinum/Etoposide Platinum will be cisplatin or carboplatin at the investigators discretion.', 'interventionNames': ['Drug: Atezolizumab']}], 'interventions': [{'name': 'Atezolizumab', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Atezolizumab/Platinum/Etoposide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsklinikum Berlin Centrum 12, Medizinische Klinik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Evangelische Lungenklinik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Klinikum der Universität zu Köln, Klinik I für Innere Medizin', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Dresden, Medizinische Klinik 1', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Klinikum der J.W. Goethe Universität, Medizinische Klinik II', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '82131', 'city': 'Gauting', 'country': 'Germany', 'facility': 'Asklepios Fachkliniken München-Gauting', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': '22927', 'city': 'Großhansdorf', 'country': 'Germany', 'facility': 'LungenClinic Grosshansdorf GmbH', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik Heidelberg gGmbH, Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '58675', 'city': 'Hemer', 'country': 'Germany', 'facility': 'Lungenklinik Hemer des Deutschen Gemeinschafts-Diakonieverbandes GmbH', 'geoPoint': {'lat': 51.38707, 'lon': 7.77019}}, {'zip': '34376', 'city': 'Immenhausen', 'country': 'Germany', 'facility': 'Lungenfachklinik Immenhausen', 'geoPoint': {'lat': 51.42763, 'lon': 9.48017}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Klinikum der Johannes Gutenberg Universität, III. Med. Klinik und Poliklinik', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '26121', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Pius Hospital, Klinik für Hämatologie und Onkologie', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Robert-Bosch-Krankenhaus GmbH', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '71364', 'city': 'Winnenden', 'country': 'Germany', 'facility': 'Rems-Murr-Klinikum Winnenden, Klinik für Hämatologie, Onkologie und Palliativmedizin', 'geoPoint': {'lat': 48.87563, 'lon': 9.39819}}], 'overallOfficials': [{'name': 'Martin Wermke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technische Universität Dresden (TUD)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}