TRIMPACT: Real-World First-Line Atezolizumab Use in Stage IV NSCLC With PD-L1 ≥50%
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAntalya Training and Research Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 1 trial groupGroup A: Atezolizumab Real-World Cohort
Trial outcomes
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.
Time frame
Up to 24 monthsSecondary outcomes
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.
Time frame
Up to 24 months2
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.
Time frame
Up to 24 months3
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.
Time frame
Up to 24 months4
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.
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Antalya Training and Research Hospital
Lead sponsor
Hoffmann-La Roche
Collaborator
Source ClinicalTrials.gov