Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 <50% (ALCG-01)

Sponsor
Gazi University
Study ID
NCT07394062
Status
Recruiting
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Conditions

  • Metastatic Nonsmall Cell Lung Cancer
  • Nonsmall Cell Lung Cancer, Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 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 — DRUG
    Nivolumab 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) — DRUG
    Ipilimumab 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.

Study Details

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.

Key Dates

Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Chemo + Pembrolizumab
    Patients receiving platinum-based chemotherapy combined with pembrolizumab as part of routine care.
  • Arm: Nivolumab + Ipilimumab + Chemotherapy
    Patients receiving nivolumab plus ipilimumab in combination with platinum-based chemotherapy as part of routine care.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 18 months ]

Central Contacts

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