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

NCT07394062 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Pembrolizumab

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.

DRUG

Nivolumab

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.

DRUG

Ipilimumab (1mg/kg)

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.

Sponsors & Collaborators

  • Gazi University

    lead OTHER

Principal Investigators

  • Ozan Yazıcı, MD · Gazi University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-08-31
Completion
2028-02-29

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07394062 on ClinicalTrials.gov