NCT07394062Recruiting
Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 <50% (ALCG-01)
A Prospective Observational Study Comparing Chemotherapy Plus Pembrolizumab Versus Nivolumab Plus Ipilimumab With Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer and PD-L1 Expression Below 50%
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 1 Feb 2026
- Primary completion date
- Aug 2027
- Lead sponsor
- Gazi University
- Diseases
- Lung cancer
- NCT number
- NCT07394062
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Feb 2026 to the primary completion date, Aug 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic therapy for metastatic non-small cell lung cancer.
Other illness
- Presence of another active malignancy requiring systemic treatment.
Other
- Participation in an interventional clinical trial that mandates treatment assignment.
- Inability to comply with routine clinical follow-up or data collection.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gazi University Faculty of Medicine, Department of Medical Oncology Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Ankara Etlik City Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.