Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT06169956
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017671', 'term': 'Platinum Compounds'}], 'ancestors': [{'id': 'D007287', 'term': 'Inorganic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free survival', 'timeFrame': 'Up to 5 years'}], 'secondaryOutcomes': [{'measure': 'Pathologic complete response (pCR) rate', 'timeFrame': 'Up to 5 years'}, {'measure': 'Rate of major pathologic response (MPR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Rate of partial pathologic response (pPR)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Rate of pathologic non-responder', 'timeFrame': 'Up to 5 years'}, {'measure': 'Rate of tumor response', 'timeFrame': 'Up to 5 years', 'description': 'Classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)'}, {'measure': 'Participant age', 'timeFrame': 'Baseline'}, {'measure': 'Participant sex', 'timeFrame': 'Baseline'}, {'measure': 'Participant insurance status', 'timeFrame': 'Baseline'}, {'measure': 'Participant employment status', 'timeFrame': 'Baseline'}, {'measure': 'Participant height in cm', 'timeFrame': 'Baseline'}, {'measure': 'Participant weight in kg', 'timeFrame': 'Baseline'}, {'measure': 'Eastern Cooperative Oncology Group Performance Status (ECOG-PS)', 'timeFrame': 'Baseline and up to 5 years', 'description': 'ECOG-PS score of 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS score of 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS score of 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. ECOG-PS score of 3 = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. ECOG-PS score of 4 = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. ECOG-PS score of 5 = Dead'}, {'measure': 'Participant medical history', 'timeFrame': 'Baseline'}, {'measure': 'Participant history of smoking', 'timeFrame': 'Baseline'}, {'measure': 'Participant concomitant treatments', 'timeFrame': 'Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years'}, {'measure': 'Participant subsequent treatments', 'timeFrame': 'Up to 5 years'}, {'measure': 'Date of initial diagnosis of NSCLC', 'timeFrame': 'Baseline'}, {'measure': 'Primary tumor assessed by histology subtype', 'timeFrame': 'Baseline'}, {'measure': 'Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA)', 'timeFrame': 'Baseline'}, {'measure': 'Location of primary tumor', 'timeFrame': 'Baseline'}, {'measure': 'Date of local relapse', 'timeFrame': 'Baseline to end of study, up to 5 years'}, {'measure': 'Location of metastases', 'timeFrame': 'Baseline to end of study, up to 5 years'}, {'measure': 'Date of metastatic diagnosis', 'timeFrame': 'Baseline to end of study, up to 5 years'}, {'measure': 'Tumor size assessed by medical imaging using x-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, bone scintigraphy, positron emission tomography-computed tomography (PET- CT)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Tumor location assessed by medical imaging using x-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, bone scintigraphy, positron emission tomography-computed tomography (PET- CT)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of participants with abnormal hematology results', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of participants with abnormal clinical chemistry results', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of participants with abnormal biomarker results', 'timeFrame': 'Baseline to end of study, up to 5 years'}, {'measure': 'Type of surgery', 'timeFrame': 'Up to 5 years'}, {'measure': 'Completeness of resection assessed by residual tumor classification', 'timeFrame': 'Up to 5 years', 'description': 'R0: no residual tumor, R1: microscopic residual tumor, R2: macroscopic residual tumor, Rx: unknown'}, {'measure': 'Number of participants with tumor resection', 'timeFrame': 'Up to 5 years'}, {'measure': 'Extend of resection (R0/R1/R2)', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of lymph nodes resected', 'timeFrame': 'Up to 5 years'}, {'measure': 'Surgical approach', 'timeFrame': 'Up to 5 years', 'description': 'Thoracotomy, minimal invasive (video-assisted thoracoscopic surgery \\[VATS\\], robotic-assisted thoracic surgery \\[RATS\\]), minimal invasive to thoracotomy (conversion)'}, {'measure': 'Length of hospital stay following surgery', 'timeFrame': 'From surgery to discharge from hospital, assessed up to 5 years'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 5 years'}, {'measure': 'Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0', 'timeFrame': 'Up to 5 years'}, {'measure': 'Patient-reported health-related Quality of Life assessed by using the validated European Quality of Life 5 Dimension 3 Level (EQ-5D-3L) questionnaire', 'timeFrame': 'Up to 5 years', 'description': 'EQ-5D-3L summary index: 1 represents perfect health, 0 represents death, negative values represent health states considered worse than death'}, {'measure': 'Time to next treatment', 'timeFrame': 'Up to 5 years', 'description': "Time between end of primary treatment (neoadjuvant treatment + surgery + if needed by physician's assessment adjuvant therapy) to start of next treatment)"}, {'measure': 'Dosing of nivolumab', 'timeFrame': 'Up to 5 years'}, {'measure': 'Treatment regimens', 'timeFrame': 'Up to 5 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Resectable Non-small Cell Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to collect and evaluate real-world data to assess the effectiveness of neoadjuvant nivolumab when given in combination with platinum-based chemotherapy in participants with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult participants aged ≥ 18 years of age or older who are diagnosed with resectable non-small cell lung cancer at high risk of recurrence and whose tumors have programmed death-ligand 1 (PD-L1) expression ≥ 1%', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Diagnosis of non-metastatic non-small cell lung cancer with tumor Programmed death-ligand 1 (PD-L1) expression level of 1% or more (tumor proportion score (TPS); according to label approved in the European Union)\n* Decision to initiate a neoadjuvant treatment with nivolumab plus platinum-based chemotherapy for treatment of non-small cell lung cancer according to current Summary of product characteristics and independent of the study\n* Willing to complete patient-reported outcome questionnaires and sufficient understanding of the German language\n* Signed written informed consent\n* Other criteria according to current Summary of product characteristics\n\nExclusion Criteria:\n\n* Current primary diagnosis of cancer other than non-small cell lung cancer that requires systemic or other treatment\n* Other contraindications according to current Summary of product characteristics'}, 'identificationModule': {'nctId': 'NCT06169956', 'acronym': 'NENI', 'briefTitle': 'An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy for Non-Metastatic NSCLC: A German, Nationwide, Prospective, Observational, Multicenter Study in Patients Scheduled to Receive 3 Cycles Nivolumab in Combination With Platinum-Based Chemotherapy for Non-Metastatic (Stage and PD-L1 Expression According to Label) Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'CA209-1210'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy', 'interventionNames': ['Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy']}], 'interventions': [{'name': 'Neoadjuvant nivolumab in combination with platinum-based chemotherapy', 'type': 'DRUG', 'description': 'Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics', 'armGroupLabels': ['Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87439', 'city': 'Kempten (Allgäu)', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Schumann, Site 0001', 'role': 'CONTACT', 'phone': '+8315302382'}], 'facility': 'Klinikverbund Allgaeu', 'geoPoint': {'lat': 47.72674, 'lon': 10.31389}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain NCT # and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}