NCT07279402

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Sep 2025Oct 2027

Study Start

First participant enrolled

September 15, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

April 30, 2026

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

December 1, 2025

Last Update Submit

April 29, 2026

Conditions

Keywords

NSCLC, PD-L1, Atezolizumab, Real World

Outcome Measures

Primary Outcomes (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.

    Up to 24 months

Secondary Outcomes (7)

  • Progression-Free Survival (PFS)

    Up to 24 months

  • Objective Response Rate (ORR)

    Up to 24 months

  • Disease Control Rate (DCR)

    Up to 24 months

  • Duration of Response (DoR)

    Up to 24 months

  • One-year Overall Survival (1-year OS)

    12 months

  • +2 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Adana City Hospital

Adana, Turkey (Türkiye)

RECRUITING

Afyonkarahisar Health Sciences University Hospital

Afyonkarahisar, 03100, Turkey (Türkiye)

RECRUITING

Ankara Oncology Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

NOT YET RECRUITING

Memorial Ankara Hospital

Ankara, 06560, Turkey (Türkiye)

NOT YET RECRUITING

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

NOT YET RECRUITING

Ankara Atatürk Sanatoryum Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

RECRUITING

Antalya City Hospital

Antalya, Turkey (Türkiye)

RECRUITING

Adnan Menderes University Faculty of Medicine Hospital

Aydin, 09100, Turkey (Türkiye)

RECRUITING

Dicle University Hospital

Diyarbakır, 21280, Turkey (Türkiye)

NOT YET RECRUITING

Trakya University Faculty of Medicine Hospital

Edirne, 22030, Turkey (Türkiye)

RECRUITING

Gaziantep City Hospital

Gaziantep, Turkey (Türkiye)

RECRUITING

Bahçelievler Memorial Hospital

Istanbul, 34180, Turkey (Türkiye)

NOT YET RECRUITING

İstanbul Medipol Mega Hospital

Istanbul, 34214, Turkey (Türkiye)

NOT YET RECRUITING

Ümraniye Training and Research Hospital

Istanbul, 34766, Turkey (Türkiye)

NOT YET RECRUITING

Marmara Üniversitesi Pendik Eğitim ve Araştırma Hastanesi

Istanbul, 34899, Turkey (Türkiye)

NOT YET RECRUITING

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Dokuz Eylul University Faculty of Medicine Hospital

Izmir, 35340, Turkey (Türkiye)

RECRUITING

Ege University Hospital

Izmir, Turkey (Türkiye)

RECRUITING

Necmettin Erbakan University Meram Faculty of Medicine Hospital

Konya, 42080, Turkey (Türkiye)

RECRUITING

Mersin University Faculty of Medicine Hospital

Mersin, 33110, Turkey (Türkiye)

RECRUITING

Ordu State Hospital

Ordu, 52200, Turkey (Türkiye)

NOT YET RECRUITING

Sakarya University Faculty of Medicine Hospital

Sakarya, 54050, Turkey (Türkiye)

RECRUITING

Medical Park Samsun Hospital

Samsun, 55080, Turkey (Türkiye)

NOT YET RECRUITING

Karadeniz Technical University Farabi Hospital

Trabzon, 61080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 1, 2025

First Posted

December 12, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

April 30, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations