Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC
NCT05950139
ALK Fusion Protein Expression, Bronchial Neoplasms
Baltimore, Maryland, United States
View Trial DetailsNCT Number: NCT07279402
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Adana City Hospital, Adana, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Antalya Training and Research Hospital
Other Gov
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
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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