TRIMPACT: Real-World First-Line Atezolizumab Use in Stage IV NSCLC With PD-L1 ≥50%
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: NSCLC Stage IV, PD-L1 Gene Mutation, Atezolizumab, Real World Study. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Primary outcome measures
- Overall Survival (OS) [Time frame: Up to 24 months]
Secondary outcome measures (7)
- Progression-Free Survival (PFS) [Time frame: Up to 24 months]
- Objective Response Rate (ORR) [Time frame: Up to 24 months]
- Disease Control Rate (DCR) [Time frame: Up to 24 months]
- Duration of Response (DoR) [Time frame: Up to 24 months]
- One-year Overall Survival (1-year OS) [Time frame: 12 months]
- Incidence of Hyperprogression [Time frame: 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 25 centers
- Adana City Hospital — Adana
- Afyonkarahisar Health Sciences University Hospital — Afyonkarahisar
- Ankara Oncology Training and Research Hospital — Ankara
- Memorial Ankara Hospital — Ankara
- Ankara Bilkent City Hospital — Ankara
- Ankara Atatürk Sanatoryum Training and Research Hospital — Ankara
- Antalya Training and Research Hospital — Antalya
- Antalya City Hospital — Antalya
- … and 17 more centers
Identifiers
NCT: NCT07279402 · MON1068.1.82