Atezolizumab, NSCLC Stage IV, PD-L1 Gene Mutation, Real World Study
Conditions
Keywords
NSCLC, PD-L1, Atezolizumab, Real World
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.
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.
Interventions
None listed
Sponsors
Antalya Training and Research Hospital
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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. |
| Objective Response Rate (ORR) | 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. |
| Disease Control Rate (DCR) | 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. |
| Duration of Response (DoR) | 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. |
| One-year Overall Survival (1-year OS) | 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. |
| Incidence of Hyperprogression | 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. |
| Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTDerya Kıvrak Salim
Outcome results
None listed