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

NCT07394062 | Recruiting

• 2 other identifiers: ALCG-01AEŞH-EK-2025-317
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

NSCLC; Metastatic Lung Cancer; Chemo-Immunotherapy; PD-L1; Progression-Free Survival; Overall Survival; Quality of Life; Patient-Reported Outcomes

Outcome Measures

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.

  Up to 18 months

Secondary Outcomes (2)

• Overall Survival (OS)

  Up to 24 months

• Health-Related Quality of Life

  Up to 18 months

Other Outcomes (3)

• Treatment Outcomes According to Antibiotic Exposure

  Up to 18 months

• Treatment Outcomes According to Dietary Patterns

  Up to 24 months

• Treatment Outcomes According to Biological Age

  Up to 24 months

Study Arms (2)

Chemo + Pembrolizumab

Patients receiving platinum-based chemotherapy combined with pembrolizumab as part of routine care.

Drug: Pembrolizumab

Nivolumab + Ipilimumab + Chemotherapy

Patients receiving nivolumab plus ipilimumab in combination with platinum-based chemotherapy as part of routine care.

Drug: Nivolumab; Drug: Ipilimumab (1mg/kg)

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.

Chemo + Pembrolizumab

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.

Nivolumab + Ipilimumab + Chemotherapy

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.

Nivolumab + Ipilimumab + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (2)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Gazi University Faculty of Medicine, Department of Medical Oncology

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

pembrolizumab; Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ozan Yazıcı, MD

  Gazi University

  STUDY CHAIR

Central Study Contacts

Orhun Akdogan, MD

CONTACT

+905375831594; orhun.akdogan@gazi.edu.tr

Osman Sutcuoglu, MD

CONTACT

sutcuogluo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)