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NCT Number: NCT07279402

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Adana City Hospital, Adana, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Derya Kıvrak Salim

CONTACT

[email protected]

+90 533 648 82 17

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Collaborators

  • Hoffmann-La Roche

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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