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

Recruitingn/aAges 18 Years - anyAllGazi University
NCT07394062 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-rela

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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%. * Initiation of first-line systemic treatment with either chemotherapy plus pembrolizumab or nivolumab plus ipilimumab in combination with chemotherapy, according to routine clinical practice. * Ability to provide informed consent. Exclusion Criteria: * 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.
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What it tests

  • Pembrolizumab
  • Nivolumab
  • Ipilimumab (1mg/kg)
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Where

2 sites
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
Gazi University Faculty of Medicine, Department of Medical Oncology
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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