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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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.
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.
Data 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab Real-World Cohort | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival (OS) is defined as the time from the initiation of atezolizumab treatment to the date of death from any cause. | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | 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. | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Derya Kıvrak Salim | Contact | +90 533 648 82 17 | derya.kivraksalim@sbu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adana City Hospital | Recruiting | Adana | Turkey (Türkiye) |
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| Objective Response Rate (ORR) | Objective response rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) during atezolizumab treatment. | Up to 24 months |
| Disease Control Rate (DCR) | 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. | Up to 24 months |
| Duration of Response (DoR) | 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. | Up to 24 months |
| One-year Overall Survival (1-year OS) | One-year overall survival is defined as the incidence of death from any cause within 12 months following the initiation of atezolizumab treatment. | 12 months |
| Incidence of Hyperprogression | 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. | Up to 24 months |
| Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | 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. | Up to 24 months |
| Afyonkarahisar Health Sciences University Hospital | Recruiting | Afyonkarahisar | 03100 | Turkey (Türkiye) |
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| Ankara Oncology Training and Research Hospital | Not yet recruiting | Ankara | 06200 | Turkey (Türkiye) |
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| Memorial Ankara Hospital | Not yet recruiting | Ankara | 06560 | Turkey (Türkiye) |
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| Ankara Bilkent City Hospital | Not yet recruiting | Ankara | 06800 | Turkey (Türkiye) |
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| Ankara Atatürk Sanatoryum Training and Research Hospital | Recruiting | Ankara | Turkey (Türkiye) |
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| Antalya Training and Research Hospital | Recruiting | Antalya | 07100 | Turkey (Türkiye) |
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| Antalya City Hospital | Recruiting | Antalya | Turkey (Türkiye) |
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| Adnan Menderes University Faculty of Medicine Hospital | Recruiting | Aydin | 09100 | Turkey (Türkiye) |
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| Dicle University Hospital | Not yet recruiting | Diyarbakır | 21280 | Turkey (Türkiye) |
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| Trakya University Faculty of Medicine Hospital | Recruiting | Edirne | 22030 | Turkey (Türkiye) |
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| Gaziantep City Hospital | Recruiting | Gaziantep | Turkey (Türkiye) |
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| Bahçelievler Memorial Hospital | Not yet recruiting | Istanbul | 34180 | Turkey (Türkiye) |
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| İstanbul Medipol Mega Hospital | Not yet recruiting | Istanbul | 34214 | Turkey (Türkiye) |
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| Ümraniye Training and Research Hospital | Not yet recruiting | Istanbul | 34766 | Turkey (Türkiye) |
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| Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi | Not yet recruiting | Istanbul | 34899 | Turkey (Türkiye) |
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| Başakşehir Çam and Sakura City Hospital | Recruiting | Istanbul | Turkey (Türkiye) |
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| Dokuz Eylul University Faculty of Medicine Hospital | Recruiting | Izmir | 35340 | Turkey (Türkiye) |
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| Ege University Hospital | Recruiting | Izmir | Turkey (Türkiye) |
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| Necmettin Erbakan University Meram Faculty of Medicine Hospital | Recruiting | Konya | 42080 | Turkey (Türkiye) |
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| Mersin University Faculty of Medicine Hospital | Recruiting | Mersin | 33110 | Turkey (Türkiye) |
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| Ordu State Hospital | Not yet recruiting | Ordu | 52200 | Turkey (Türkiye) |
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| Sakarya University Faculty of Medicine Hospital | Recruiting | Sakarya | 54050 | Turkey (Türkiye) |
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| Medical Park Samsun Hospital | Not yet recruiting | Samsun | 55080 | Turkey (Türkiye) |
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| Karadeniz Technical University Farabi Hospital | Recruiting | Trabzon | 61080 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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