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

April 29, 2026 updated by: Derya Kivrak salim, Antalya Training and Research Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye)
        • Recruiting
        • Adana City Hospital
        • Principal Investigator:
          • Timuçin Çil, MD
        • Contact:
      • Afyonkarahisar, Turkey (Türkiye), 03100
        • Recruiting
        • Afyonkarahisar Health Sciences University Hospital
        • Contact:
        • Principal Investigator:
          • Hacer Demir
      • Ankara, Turkey (Türkiye), 06800
        • Not yet recruiting
        • Ankara Bilkent City Hospital
        • Contact:
        • Principal Investigator:
          • Burak Bilgin
      • Ankara, Turkey (Türkiye), 06200
        • Not yet recruiting
        • Ankara Oncology Training and Research Hospital
        • Principal Investigator:
          • Ozturk Ates
        • Contact:
      • Ankara, Turkey (Türkiye), 06560
        • Not yet recruiting
        • Memorial Ankara Hospital
        • Principal Investigator:
          • Umut Demirci
        • Contact:
        • Sub-Investigator:
          • İrem Bilgetekin
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara Atatürk Sanatoryum Training and Research Hospital
        • Contact:
        • Principal Investigator:
          • Serdar Karakaya, MD
      • Antalya, Turkey (Türkiye), 07100
        • Recruiting
        • Antalya Training And Research Hospital
        • Principal Investigator:
          • Derya Kıvrak Salim
        • Contact:
        • Sub-Investigator:
          • Yusuf İlhan
      • Antalya, Turkey (Türkiye)
        • Recruiting
        • Antalya City Hospital
        • Contact:
        • Principal Investigator:
          • Yusuf İlhan, MD
      • Aydin, Turkey (Türkiye), 09100
        • Recruiting
        • Adnan Menderes University Faculty of Medicine Hospital
        • Principal Investigator:
          • Esin Oktay
        • Contact:
      • Diyarbakır, Turkey (Türkiye), 21280
        • Not yet recruiting
        • Dicle University Hospital
        • Principal Investigator:
          • Muhammet Ali Kaplan
        • Contact:
      • Edirne, Turkey (Türkiye), 22030
        • Recruiting
        • Trakya University Faculty of Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Muhammet Bekir Hacıoğlu
      • Gaziantep, Turkey (Türkiye)
        • Recruiting
        • Gaziantep City Hospital
        • Contact:
        • Principal Investigator:
          • Mustafa Seyyar, MD
      • Istanbul, Turkey (Türkiye), 34180
        • Not yet recruiting
        • Bahçelievler Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Kezban Nur Pilancı
      • Istanbul, Turkey (Türkiye), 34214
        • Not yet recruiting
        • İstanbul Medipol Mega Hospital
        • Principal Investigator:
          • Ahmet Bilici
        • Contact:
      • Istanbul, Turkey (Türkiye), 34766
        • Not yet recruiting
        • Umraniye Training and Research Hospital
        • Contact:
        • Principal Investigator:
          • Melike Özçelik
      • Istanbul, Turkey (Türkiye), 34899
        • Not yet recruiting
        • Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi
        • Contact:
        • Principal Investigator:
          • Osman Köstek
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Basaksehir Cam and Sakura City Hospital
        • Contact:
        • Principal Investigator:
          • Tuğrul Burak Genç, MD
      • Izmir, Turkey (Türkiye), 35340
        • Recruiting
        • Dokuz Eylul University Faculty of Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Elif Atag
      • Izmir, Turkey (Türkiye)
        • Recruiting
        • Ege University Hospital
        • Contact:
        • Principal Investigator:
          • Hasan Çağrı Yıldırım, MD
      • Konya, Turkey (Türkiye), 42080
        • Recruiting
        • Necmettin Erbakan University Meram Faculty of Medicine Hospital
        • Contact:
        • Principal Investigator:
          • Melek Karakurt Eryılmaz
      • Mersin, Turkey (Türkiye), 33110
        • Recruiting
        • Mersin University Faculty of Medicine Hospital
        • Principal Investigator:
          • Vehbi Erçolak
        • Contact:
        • Sub-Investigator:
          • Kadir Eser
      • Ordu, Turkey (Türkiye), 52200
        • Not yet recruiting
        • Ordu State Hospital
        • Contact:
        • Principal Investigator:
          • Serkan Enki
      • Sakarya, Turkey (Türkiye), 54050
        • Recruiting
        • Sakarya University Faculty of Medicine Hospital
        • Contact:
        • Principal Investigator:
          • İlhan Hacıbekiroğlu
        • Sub-Investigator:
          • Hasibe Bilge Gür
      • Samsun, Turkey (Türkiye), 55080
        • Not yet recruiting
        • Medical Park Samsun Hospital
        • Principal Investigator:
          • Yasemin Kemal
        • Contact:
      • Trabzon, Turkey (Türkiye), 61080
        • Recruiting
        • Karadeniz Technical University Farabi Hospital
        • Contact:
        • Principal Investigator:
          • Atila Yıldırım

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 24 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to 24 months
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
Objective Response Rate (ORR)
Time Frame: Up to 24 months
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)
Time Frame: Up to 24 months
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)
Time Frame: Up to 24 months
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)
Time Frame: 12 months
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
Time Frame: Up to 24 months
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)
Time Frame: Up to 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Collaborators

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 12, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MON1068.1.82

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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