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TRIMPACT: Real-World First-Line Atezolizumab Use in Stage IV NSCLC With PD-L1 ≥50%

NCT ID: NCT07279402

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-15

Study Completion Date

2027-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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NSCLC Stage IV PD-L1 Gene Mutation Atezolizumab Real World Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent form.
* Diagnosis of stage IV non-small cell lung cancer.
* Male or female patients aged 18 years or older.
* Patients who have been prescribed atezolizumab in accordance with routine clinical practice and the locally approved indication in Türkiye.
* Patients who have received up to 3 cycles of atezolizumab at the screening visit.

Exclusion Criteria

* Patients who are not receiving atezolizumab for the treatment of lung cancer according to standard of care and the approved indication.
* Known or suspected hypersensitivity to atezolizumab.
* Pregnant or breastfeeding women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Derya Kivrak salim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Afyonkarahisar Health Sciences University Hospital

Afyonkarahisar, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Memorial Ankara Hospital

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Ankara Bilkent City Hospital

Ankara, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Antalya Training and Research Hospital

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Adnan Menderes University Faculty of Medicine Hospital

Aydin, , Turkey (Türkiye)

Site Status RECRUITING

Dicle University Hospital

Diyarbakır, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Trakya University Faculty of Medicine Hospital

Edirne, , Turkey (Türkiye)

Site Status RECRUITING

Bahçelievler Memorial Hospital

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

İstanbul Medipol Mega Hospital

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Ümraniye Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Dokuz Eylul University Faculty of Medicine Hospital

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Necmettin Erbakan University Meram Faculty of Medicine Hospital

Konya, , Turkey (Türkiye)

Site Status RECRUITING

Mersin University Faculty of Medicine Hospital

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Ordu State Hospital

Ordu, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Sakarya University Faculty of Medicine Hospital

Sakarya, , Turkey (Türkiye)

Site Status RECRUITING

Medical Park Samsun Hospital

Samsun, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Karadeniz Technical University Farabi Hospital

Trabzon, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Derya Kıvrak Salim

Role: CONTACT

[email protected]
+90 533 648 82 17

Facility Contacts

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Hacer Demir

Role: primary

[email protected]
+90 505 504 40 11

Öztürk Ateş

Role: primary

[email protected]
+90 532 796 36 62

Umut Demirci

Role: primary

[email protected]
+90 506 752 12 75

Burak Bilgin

Role: primary

[email protected]
+90 536 413 10 34

Derya Kıvrak Salim

Role: primary

[email protected]
+90 533 648 82 17

Esin Oktay

Role: primary

[email protected]
+90 505 317 06 39

Muhammet Ali Kaplan

Role: primary

[email protected]
+90533 767 71 31

Muhammet Bekir Hacıoğlu

Role: primary

[email protected]
+90 533 436 46 78

Kezban Nur Pilancı

Role: primary

[email protected]
+90 532 557 39 99

Ahmet Bilici

Role: primary

[email protected]
+90 532 528 04 86

Melike Özçelik

Role: primary

[email protected]
+90 506 297 97 94

Osman Köstek

Role: primary

[email protected]
+90 554 585 73 90

Elif Atağ

Role: primary

[email protected]
+90 505 785 45 55

Melek Karakurt Eryılmaz

Role: primary

[email protected]
+90 505 677 61 72

Vehbi Erçolak

Role: primary

[email protected]
+90 532 227 22 76

Serkan Enki

Role: primary

[email protected]
+90 533 620 34 50

İlhan Hacıbekiroğlu

Role: primary

[email protected]
+90 505 478 55 76

Yasemin Kemal

Role: primary

[email protected]
+90 533 429 67 97

Atila Yıldırım

Role: primary

[email protected]
+90 543 477 33 42

Other Identifiers

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MON1068.1.82

Identifier Type: -

Identifier Source: org_study_id

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