Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT07279402
Status:
RECRUITING
Last Update Posted:
2025-12-12
First Post:
2025-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TRIMPACT: Real-World First-Line Atezolizumab Use in Stage IV NSCLC With PD-L1 ≥50%
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2025-12-01', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 24 months', 'description': 'Overall survival (OS) is defined as the time from the initiation of atezolizumab treatment to the date of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 24 months', 'description': 'Progression-free survival (PFS) is defined as the time from the initiation of atezolizumab treatment to the first date of objectively documented disease progression (PD) or death from any cause, whichever occurs first. Progression will be assessed by the treating physician according to local standard clinical practice or RECIST criteria when available.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 24 months', 'description': 'Objective response rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) during atezolizumab treatment.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Up to 24 months', 'description': 'Disease control rate (DCR) is defined as the proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD) during atezolizumab treatment.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Up to 24 months', 'description': 'Duration of response (DoR) is defined as the time from the date of first documented complete response (CR) or partial response (PR) to the first date of objectively documented disease progression or death from any cause, whichever occurs first.'}, {'measure': 'One-year Overall Survival (1-year OS)', 'timeFrame': '12 months', 'description': 'One-year overall survival is defined as the incidence of death from any cause within 12 months following the initiation of atezolizumab treatment.'}, {'measure': 'Incidence of Hyperprogression', 'timeFrame': 'Up to 24 months', 'description': 'The incidence of hyperprogression is defined as the proportion of patients who exhibit rapid tumor progression after initiation of atezolizumab, according to the criteria specified in the study protocol.'}, {'measure': 'Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)', 'timeFrame': 'Up to 24 months', 'description': 'The incidence, nature, and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0). Safety evaluations include monitoring and recording of AEs and SAEs, laboratory results, vital signs, and other clinically relevant assessments performed as part of routine clinical practice.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC, PD-L1, Atezolizumab, Real World'], 'conditions': ['NSCLC Stage IV', 'PD-L1 Gene Mutation', 'Atezolizumab', 'Real World Study']}, 'descriptionModule': {'briefSummary': 'This prospective, multicenter, real-world observational study aims to evaluate the clinical outcomes of first-line atezolizumab monotherapy in patients with stage IV non-small cell lung cancer (NSCLC) with PD-L1 tumor cell expression ≥50% and no targetable mutations. The study aim to determine how atezolizumab performs in routine clinical practice with respect to survival, treatment response, and safety outcomes in this patient population in Türkiye.', 'detailedDescription': 'This study is a prospective, multicenter, observational study designed to generate real-world evidence on the routine first-line use of atezolizumab in patients with advanced non-small cell lung cancer (NSCLC) who exhibit high PD-L1 expression and have no targetable mutations. The study does not impose any protocol-mandated procedures or intervention requirements, and all assessments, treatments, and follow-up visits are carried out according to local standards of care at each participating center.\n\nData will be collected prospectively from routine medical records and will include information typically obtained during standard clinical management, such as imaging assessments, laboratory results, performance status evaluations, treatment exposure, and safety monitoring. Clinical outcomes will be analyzed to describe real-world treatment patterns, variations in clinical practice, and survival and safety trends in a national cohort. Approximately 150 patients are expected to be enrolled to ensure adequate precision in estimating long-term outcomes within this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with stage IV non-small cell lung cancer receiving first-line atezolizumab as part of routine clinical practice at participating oncology centers in Türkiye. The study population reflects real-world patients treated according to local standards of care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form.\n* Diagnosis of stage IV non-small cell lung cancer.\n* Male or female patients aged 18 years or older.\n* Patients who have been prescribed atezolizumab in accordance with routine clinical practice and the locally approved indication in Türkiye.\n* Patients who have received up to 3 cycles of atezolizumab at the screening visit.\n\nExclusion Criteria:\n\n* Patients who are not receiving atezolizumab for the treatment of lung cancer according to standard of care and the approved indication.\n* Known or suspected hypersensitivity to atezolizumab.\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT07279402', 'briefTitle': 'TRIMPACT: Real-World First-Line Atezolizumab Use in Stage IV NSCLC With PD-L1 ≥50%', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'TRIMPACT: A Prospective Real-World Study of Atezolizumab Monotherapy as First-Line (Stage IV) Treatment in Patients With Non-Small Cell Lung Cancer With PD-L1 Tumor Cell Expression ≥50% and No Targetable Mutations', 'orgStudyIdInfo': {'id': 'MON1068.1.82'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atezolizumab Real-World Cohort', 'description': 'This observational cohort consists of patients with stage IV non-small cell lung cancer (NSCLC) who receive first-line atezolizumab in routine clinical practice. Participants are included based on real-world treatment decisions made by their physicians, and no study-mandated interventions or procedures are required. The cohort reflects patients treated according to local standards of care, allowing evaluation of real-life treatment patterns, clinical outcomes, and safety in this population.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03100', 'city': 'Afyonkarahisar', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Hacer Demir', 'role': 'CONTACT', 'email': 'drhacerdemir@gmail.com', 'phone': '+90 505 504 40 11'}, {'name': 'Hacer Demir', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Afyonkarahisar Health Sciences University Hospital', 'geoPoint': {'lat': 38.75667, 'lon': 30.54333}}, {'zip': '06200', 'city': 'Ankara', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Öztürk Ateş', 'role': 'CONTACT', 'email': 'dr.ozturkates@gmail.com', 'phone': '+90 532 796 36 62'}, {'name': 'Öztürk Ateş', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ankara Oncology Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06560', 'city': 'Ankara', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Umut Demirci', 'role': 'CONTACT', 'email': 'umutdemirci.klnk@gmail.com', 'phone': '+90 506 752 12 75'}, {'name': 'Umut Demirci', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'İrem Bilgetekin', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Memorial Ankara Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '06800', 'city': 'Ankara', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Burak Bilgin', 'role': 'CONTACT', 'email': 'drbbilgin@gmail.com', 'phone': '+90 536 413 10 34'}, {'name': 'Burak Bilgin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '07100', 'city': 'Antalya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Derya Kıvrak Salim', 'role': 'CONTACT', 'email': 'derya.kivraksalim@sbu.edu.tr', 'phone': '+90 533 648 82 17'}, {'name': 'Derya Kıvrak Salim', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yusuf İlhan', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Antalya Training and Research Hospital', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'zip': '09100', 'city': 'Aydin', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Esin Oktay', 'role': 'CONTACT', 'email': 'esinct@gmail.com', 'phone': '+90 505 317 06 39'}, {'name': 'Esin Oktay', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Adnan Menderes University Faculty of Medicine Hospital', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}, {'zip': '21280', 'city': 'Diyarbakır', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Muhammet Ali Kaplan', 'role': 'CONTACT', 'email': 'drmalikaplan@gmail.com', 'phone': '+90533 767 71 31'}, {'name': 'Muhammet Ali Kaplan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dicle University Hospital', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}, {'zip': '22030', 'city': 'Edirne', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Muhammet Bekir Hacıoğlu', 'role': 'CONTACT', 'email': 'muhammetbekirhacioglu@gmail.com', 'phone': '+90 533 436 46 78'}, {'name': 'Muhammet Bekir Hacıoğlu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Trakya University Faculty of Medicine Hospital', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}, {'zip': '34180', 'city': 'Istanbul', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kezban Nur Pilancı', 'role': 'CONTACT', 'email': 'kezbannurgunes@gmail.com', 'phone': '+90 532 557 39 99'}, {'name': 'Kezban Nur Pilancı', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bahçelievler Memorial Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34214', 'city': 'Istanbul', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Ahmet Bilici', 'role': 'CONTACT', 'email': 'ahmetknower@yahoo.com', 'phone': '+90 532 528 04 86'}, {'name': 'Ahmet Bilici', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'İstanbul Medipol Mega Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34766', 'city': 'Istanbul', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Melike Özçelik', 'role': 'CONTACT', 'email': 'drmelike.ozcelik@gmail.com', 'phone': '+90 506 297 97 94'}, {'name': 'Melike Özçelik', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ümraniye Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34899', 'city': 'Istanbul', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Osman Köstek', 'role': 'CONTACT', 'email': 'osmankostek@yahoo.com', 'phone': '+90 554 585 73 90'}, {'name': 'Osman Köstek', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35340', 'city': 'Izmir', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Elif Atağ', 'role': 'CONTACT', 'email': 'elifatag@gmail.com', 'phone': '+90 505 785 45 55'}, {'name': 'Elif Atağ', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dokuz Eylul University Faculty of Medicine Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '42080', 'city': 'Konya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Melek Karakurt Eryılmaz', 'role': 'CONTACT', 'email': 'drangelkarakurt@hotmail.com', 'phone': '+90 505 677 61 72'}, {'name': 'Melek Karakurt Eryılmaz', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Necmettin Erbakan University Meram Faculty of Medicine Hospital', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}, {'zip': '33110', 'city': 'Mersin', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Vehbi Erçolak', 'role': 'CONTACT', 'email': 'vehbiercolak.clinicaltrials@gmail.com', 'phone': '+90 532 227 22 76'}, {'name': 'Vehbi Erçolak', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kadir Eser', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mersin University Faculty of Medicine Hospital', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}, {'zip': '52200', 'city': 'Ordu', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Serkan Enki', 'role': 'CONTACT', 'email': 'dr.serkan34@hotmail.com', 'phone': '+90 533 620 34 50'}, {'name': 'Serkan Enki', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ordu State Hospital', 'geoPoint': {'lat': 40.97782, 'lon': 37.89047}}, {'zip': '54050', 'city': 'Sakarya', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'İlhan Hacıbekiroğlu', 'role': 'CONTACT', 'email': 'ilhanhbo@hotmail.com', 'phone': '+90 505 478 55 76'}, {'name': 'İlhan Hacıbekiroğlu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hasibe Bilge Gür', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sakarya University Faculty of Medicine Hospital', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}, {'zip': '55080', 'city': 'Samsun', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Yasemin Kemal', 'role': 'CONTACT', 'email': 'dryaseminkemal@gmail.com', 'phone': '+90 533 429 67 97'}, {'name': 'Yasemin Kemal', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medical Park Samsun Hospital', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}, {'zip': '61080', 'city': 'Trabzon', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Atila Yıldırım', 'role': 'CONTACT', 'email': 'atilayildirim55@gmail.com', 'phone': '+90 543 477 33 42'}, {'name': 'Atila Yıldırım', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karadeniz Technical University Farabi Hospital', 'geoPoint': {'lat': 41.005, 'lon': 39.72694}}], 'centralContacts': [{'name': 'Derya Kıvrak Salim', 'role': 'CONTACT', 'email': 'derya.kivraksalim@sbu.edu.tr', 'phone': '+90 533 648 82 17'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Derya Kivrak salim', 'investigatorAffiliation': 'Antalya Training and Research Hospital'}}}}