Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 <50% (ALCG-01)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGazi University
About this trial
Patients with metastatic non-small cell lung cancer (NSCLC) and programmed death-ligand 1 (PD-L1) expression below 50% are commonly treated with different chemo-immunotherapy regimens in routine clinical practice. Although these regimens are widely used, comparative real-world data on survival outcomes and patient-reported quality of life are limited.
This prospective observational study aims to compare two commonly used treatment approaches in patients with metastatic NSCLC and PD-L1 expression \<50%: chemotherapy plus pembrolizumab versus nivolumab plus ipilimumab combined with chemotherapy. Patients will receive treatment according to routine clinical decisions made by their treating physicians; no treatment assignment or intervention will be performed as part of the study.
The primary outcomes of the study are progression-free survival and overall survival. In addition, health-related quality of life will be assessed using validated patient-reported outcome questionnaires during routine follow-up.
Exploratory analyses will examine treatment outcomes in relation to selected clinical and patient-related factors, such as biological age, antibiotic exposure, and dietary patterns, in subsets of patients with available data.
The results of this study are expected to provide real-world evidence on survival and quality of life outcomes associated with commonly used chemo-immunotherapy strategies in metastatic NSCLC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Histologically or cytologically confirmed non-small cell lung cancer.
Metastatic (stage IV) disease at the time of study entry.
Tumor PD-L1 expression <50%.
Disqualifiers
Prior systemic therapy for metastatic non-small cell lung cancer.
Participation in an interventional clinical trial that mandates treatment assignment.
Presence of another active malignancy requiring systemic treatment.
Inability to comply with routine clinical follow-up or data collection.
Trial population
The study population consists of adult patients with metastatic non-small cell lung cancer and PD-L1 expression below 50% who are receiving standard first-line chemo-immunotherapy regimens in routine clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Pembrolizumab
DrugPembrolizumab administered as part of routine clinical care in combination with platinum-based chemotherapy, according to standard clinical practice. Treatment selection, dosing, and scheduling are determined by the treating physician and are not protocol-mandated.
Nivolumab
DrugNivolumab administered as part of routine clinical care in combination with ipilimumab and platinum-based chemotherapy, according to standard clinical practice. Treatment selection, dosing, scheduling, and duration are determined by the treating physician and are not protocol-mandated.
Ipilimumab (1mg/kg)
DrugIpilimumab administered as part of routine clinical care in combination with nivolumab and platinum-based chemotherapy, according to standard clinical practice. Treatment selection, dosing, scheduling, and duration are determined by the treating physician and are not protocol-mandated.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Chemo + Pembrolizumab1 intervention
Group B: Nivolumab + Ipilimumab + Chemotherapy2 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS)
Progression-free survival, defined as the time from treatment initiation to radiologic disease progression or death from any cause, whichever occurs first, assessed according to routine clinical and radiological evaluations.
Time frame
Up to 18 monthsSecondary outcomes
1
Overall Survival (OS)
Overall survival, defined as the time from treatment initiation to death from any cause.
Time frame
Up to 24 months2
Health-Related Quality of Life
Health-related quality of life assessed using the EORTC QLQ-C30 questionnaire, including the global health status/quality of life score, administered during routine follow-up.
Time frame
Up to 18 monthsOther outcomes
1
Treatment Outcomes According to Antibiotic Exposure
Association between antibiotic exposure during treatment and clinical outcomes, including progression-free survival and overall survival, analyzed in patients with available antibiotic use data.
Time frame
Up to 18 months2
Treatment Outcomes According to Dietary Patterns
Association between dietary patterns assessed by patient questionnaires and treatment outcomes, including progression-free survival and overall survival, analyzed in a subset of patients with available dietary data.
Time frame
Up to 24 months3
Treatment Outcomes According to Biological Age
Association between biological age metrics and treatment outcomes, including progression-free survival and overall survival, analyzed in patients with available data.
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov