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NSCLC Stage IVNCT07279402

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

An observational study of NSCLC Stage IV and PD-L1 Gene Mutation, run by Antalya Training and Research Hospital at 25 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC Stage IV, PD-L1 Gene Mutation, Atezolizumab
Type of treatment
Injection or infusion
How many people
150 participants
Where
25 sitesTurkey (Türkiye)
Study dates
15 Sep 2025to 1 Oct 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Derya Kıvrak Salim contact

+90 533 648 82 17

derya.kivraksalim@sbu.edu.tr

25 sites in 1 country

Turkey (Türkiye)25 sites, 25 recruiting

  • Adana City Hospital

    Adana

    Timuçin Çil, MD, +90 533 144 76 19, drtimucincil@gmail.com

    Timuçin Çil, MD

    Recruiting

  • Afyonkarahisar Health Sciences University Hospital

    Afyonkarahisar, 03100

    Hacer Demir, +90 505 504 40 11, drhacerdemir@gmail.com

    Hacer Demir

    Recruiting

  • Ankara Oncology Training and Research Hospital

    Ankara, 06200

    Öztürk Ateş, +90 532 796 36 62, dr.ozturkates@gmail.com

    Öztürk Ateş

    Not yet recruiting

  • Memorial Ankara Hospital

    Ankara, 06560

    Umut Demirci, +90 506 752 12 75, umutdemirci.klnk@gmail.com

    Umut Demirci

    Not yet recruiting

  • Ankara Bilkent City Hospital

    Ankara, 06800

    Burak Bilgin, +90 536 413 10 34, drbbilgin@gmail.com

    Burak Bilgin

    Not yet recruiting

  • Ankara Atatürk Sanatoryum Training and Research Hospital

    Ankara

    Serdar Karakaya, MD, +90 505 333 13 39, drserdarkarakaya@gmail.com

    Serdar Karakaya, MD

    Recruiting

  • Antalya Training and Research Hospital

    Antalya, 07100

    Derya Kıvrak Salim, +90 533 648 82 17, derya.kivraksalim@sbu.edu.tr

    Derya Kıvrak Salim

    Recruiting

  • Antalya City Hospital

    Antalya

    Yusuf İlhan, MD, +90 505 608 62 51, dryusufilhan@gmail.com

    Yusuf İlhan, MD

    Recruiting

  • Adnan Menderes University Faculty of Medicine Hospital

    Aydin, 09100

    Esin Oktay, +90 505 317 06 39, esinct@gmail.com

    Esin Oktay

    Recruiting

  • Dicle University Hospital

    Diyarbakır, 21280

    Muhammet Ali Kaplan, +90533 767 71 31, drmalikaplan@gmail.com

    Muhammet Ali Kaplan

    Not yet recruiting

  • Trakya University Faculty of Medicine Hospital

    Edirne, 22030

    Muhammet Bekir Hacıoğlu, +90 533 436 46 78, muhammetbekirhacioglu@gmail.com

    Muhammet Bekir Hacıoğlu

    Recruiting

  • Gaziantep City Hospital

    Gaziantep

    Mustafa Seyyar, MD, +90 551 711 44 27, mustafaseyyar27@hotmail.com

    Mustafa Seyyar, MD

    Recruiting

  • Bahçelievler Memorial Hospital

    Istanbul, 34180

    Kezban Nur Pilancı, +90 532 557 39 99, kezbannurgunes@gmail.com

    Kezban Nur Pilancı

    Not yet recruiting

  • İstanbul Medipol Mega Hospital

    Istanbul, 34214

    Ahmet Bilici, +90 532 528 04 86, ahmetknower@yahoo.com

    Ahmet Bilici

    Not yet recruiting

  • Ümraniye Training and Research Hospital

    Istanbul, 34766

    Melike Özçelik, +90 506 297 97 94, drmelike.ozcelik@gmail.com

    Melike Özçelik

    Not yet recruiting

  • Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi

    Istanbul, 34899

    Osman Köstek, +90 554 585 73 90, osmankostek@yahoo.com

    Osman Köstek

    Not yet recruiting

  • Başakşehir Çam and Sakura City Hospital

    Istanbul

    Tuğrul Burak Genç, MD, +90 555 510 19 09, drtugrulburakgenc@gmail.com

    Tuğrul Burak Genç, MD

    Recruiting

  • Dokuz Eylul University Faculty of Medicine Hospital

    Izmir, 35340

    Elif Atağ, +90 505 785 45 55, elifatag@gmail.com

    Elif Atağ

    Recruiting

  • Ege University Hospital

    Izmir

    Hasan Çağrı Yıldırım, MD, +90 542 547 61 38, hasan.cagri.yildirim@ege.edu.tr

    Hasan Çağrı Yıldırım, MD

    Recruiting

  • Necmettin Erbakan University Meram Faculty of Medicine Hospital

    Konya, 42080

    Melek Karakurt Eryılmaz, +90 505 677 61 72, drangelkarakurt@hotmail.com

    Melek Karakurt Eryılmaz

    Recruiting

  • Mersin University Faculty of Medicine Hospital

    Mersin, 33110

    Vehbi Erçolak, +90 532 227 22 76, vehbiercolak.clinicaltrials@gmail.com

    Vehbi Erçolak

    Recruiting

  • Ordu State Hospital

    Ordu, 52200

    Serkan Enki, +90 533 620 34 50, dr.serkan34@hotmail.com

    Serkan Enki

    Not yet recruiting

  • Sakarya University Faculty of Medicine Hospital

    Sakarya, 54050

    İlhan Hacıbekiroğlu, +90 505 478 55 76, ilhanhbo@hotmail.com

    İlhan Hacıbekiroğlu

    Recruiting

  • Medical Park Samsun Hospital

    Samsun, 55080

    Yasemin Kemal, +90 533 429 67 97, dryaseminkemal@gmail.com

    Yasemin Kemal

    Not yet recruiting

  • Karadeniz Technical University Farabi Hospital

    Trabzon, 61080

    Atila Yıldırım, +90 543 477 33 42, atilayildirim55@gmail.com

    Atila Yıldırım

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
NSCLC, PD-L1, Atezolizumab, Real World
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07279402
Study groupRoleWhat they receive
Atezolizumab Real-World CohortThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 months

Secondary outcomes (7)

  1. 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.

    Measured: Up to 24 months

  2. 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.

    Measured: Up to 24 months

  3. 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.

    Measured: Up to 24 months

  4. 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.

    Measured: Up to 24 months

  5. 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.

    Measured: 12 months

  6. 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.

    Measured: Up to 24 months

  7. 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.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start15 Sep 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07279402
Sponsor's protocol ID
MON1068.1.82
Status last verified
Dec 2025
First submitted
1 Dec 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of NSCLC Stage IV and PD-L1 Gene Mutation, run by Antalya Training and Research Hospital at 25 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Derya Kıvrak Salim (+90 533 648 82 17, derya.kivraksalim@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07279402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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