Nonsmall Cell Lung Cancer, Stage IVALCG-01NCT07394062
Real-World Comparison of Chemo-Immunotherapy Regimens in Metastatic NSCLC With PD-L1 <50% (ALCG-01)
An observational study of Nonsmall Cell Lung Cancer, Stage IV and Metastatic Nonsmall Cell Lung Cancer, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer, Stage IV, Metastatic Nonsmall Cell Lung Cancer
- What is being tested?
- Pembrolizumab, Nivolumab and Ipilimumab (1mg/kg)
- How many people
- 400 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2026to Feb 2028
- How long will I take part?
- 18 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Osman Sutcuoglu, MD contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara
Enes Yeşilbaş, MD, +905321795590, yesilbas126@gmail.com
- Recruiting
Gazi University Faculty of Medicine, Department of Medical Oncology
Ankara
Orhun Akdogan, MD, +905375831594, orhun.akdogan@gazi.edu.tr
About this study
Official title: 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%
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.
Read more
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.
Read the detailed description
This is a prospective, observational cohort study conducted in patients with metastatic non-small cell lung cancer (NSCLC) and programmed death-ligand 1 (PD-L1) expression below 50% who are treated in routine clinical practice.
Eligible patients will receive systemic treatment according to standard-of-care decisions made by their treating physicians. Two commonly used treatment approaches will be observed: chemotherapy combined with pembrolizumab, and nivolumab plus ipilimumab administered in combination with chemotherapy. No randomization, protocol-driven treatment assignment, or experimental intervention will be performed as part of the study.
The primary objectives of the study are to compare progression-free survival (PFS) and overall survival (OS) between the two treatment approaches. Survival outcomes will be assessed using standard clinical and radiological follow-up data collected during routine care.
Secondary objectives include the evaluation of health-related quality of life and patient-reported outcomes. Quality of life will be assessed using validated questionnaires administered during routine follow-up visits, including global quality of life, functional status, cognitive function, and psychological well-being.
In addition to the primary and secondary objectives, exploratory analyses are planned to investigate the association between treatment outcomes and selected patient-related factors. These include biological age metrics, exposure to antibiotics during treatment, and dietary patterns assessed through patient questionnaires. These analyses will be conducted in subsets of patients with available and complete data for the relevant variables.
As an observational real-world study, missing data are anticipated for some variables, particularly patient-reported and lifestyle-related measures. All analyses will be performed using appropriate statistical methods, and results from exploratory analyses will be interpreted as hypothesis-generating.
This study is designed to provide prospective real-world evidence on the comparative effectiveness and patient-reported outcomes of widely used chemo-immunotherapy regimens in metastatic NSCLC patients with PD-L1 expression below 50%.
- Being tested
- Pembrolizumab, Nivolumab, Ipilimumab (1mg/kg)
- Keywords
- NSCLC, Metastatic Lung Cancer, Chemo-Immunotherapy, PD-L1, Progression-Free Survival, Overall Survival, Quality of Life, Patient-Reported Outcomes
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
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.
NivolumabDrug
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 group | Role | What they receive |
|---|---|---|
| Chemo + Pembrolizumab | Patients receiving platinum-based chemotherapy combined with pembrolizumab as part of routine care. Receives: Drug: Pembrolizumab | |
| Nivolumab + Ipilimumab + Chemotherapy | Patients receiving nivolumab plus ipilimumab in combination with platinum-based chemotherapy as part of routine care. Receives: Drug: Nivolumab; Drug: Ipilimumab (1mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 months
Secondary outcomes (2)
Overall Survival (OS)
Overall survival, defined as the time from treatment initiation to death from any cause.
Measured: Up to 24 months
Health-Related Quality of Life
Health-related quality of life assessed using the EORTC QLQ-C30 questionnaire, including the global health status/quality of life score, administered during routine follow-up.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung Cancer, Stage IVStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orhun Akdoğan, Gazi University
- Investigators
- Ozan Yazıcı, MD, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394062
- Sponsor's protocol ID
- ALCG-01
- Other IDs
- AEŞH-EK-2025-317
- Acronym
- ALCG-01
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves prospectively collected clinical and patient-reported data obtained as part of routine clinical care, and data sharing was not included in the original study protocol or informed consent. Any data use will be limited to the approved analyses within the study framework.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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%
- ClinicalTrials.gov ID
- NCT07394062
- Acronym / sponsor ID
- ALCG-01 / ALCG-01
- Keywords
- NSCLC, Metastatic Lung Cancer, Chemo-Immunotherapy, PD-L1, Progression-Free Survival, Overall Survival, Quality of Life, Patient-Reported Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, observational cohort study conducted in patients with metastatic non-small cell lung cancer (NSCLC) and programmed death-ligand 1 (PD-L1) expression below 50% who are treated in routine clinical practice.
Eligible patients will receive systemic treatment according to standard-of-care decisions made by their treating physicians. Two commonly used treatment approaches will be observed: chemotherapy combined with pembrolizumab, and nivolumab plus ipilimumab administered in combination with chemotherapy. No randomization, protocol-driven treatment assignment, or experimental intervention will be performed as part of the study.
The primary objectives of the study are to compare progression-free survival (PFS) and overall survival (OS) between the two treatment approaches. Survival outcomes will be assessed using standard clinical and radiological follow-up data collected during routine care.
Secondary objectives include the evaluation of health-related quality of life and patient-reported outcomes. Quality of life will be assessed using validated questionnaires administered during routine follow-up visits, including global quality of life, functional status, cognitive function, and psychological well-being.
In addition to the primary and secondary objectives, exploratory analyses are planned to investigate the association between treatment outcomes and selected patient-related factors. These include biological age metrics, exposure to antibiotics during treatment, and dietary patterns assessed through patient questionnaires. These analyses will be conducted in subsets of patients with available and complete data for the relevant variables.
As an observational real-world study, missing data are anticipated for some variables, particularly patient-reported and lifestyle-related measures. All analyses will be performed using appropriate statistical methods, and results from exploratory analyses will be interpreted as hypothesis-generating.
This study is designed to provide prospective real-world evidence on the comparative effectiveness and patient-reported outcomes of widely used chemo-immunotherapy regimens in metastatic NSCLC patients with PD-L1 expression below 50%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemo + Pembrolizumab | – | Drug: PembrolizumabPatients receiving platinum-based chemotherapy combined with pembrolizumab as part of routine care. |
| Nivolumab + Ipilimumab + Chemotherapy | – | Drug: Nivolumab, Drug: Ipilimumab (1mg/kg)Patients receiving nivolumab plus ipilimumab in combination with platinum-based chemotherapy as part of routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab 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 | Chemo + Pembrolizumab |
| NivolumabNivolumab 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 | Nivolumab + Ipilimumab + Chemotherapy |
| 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. | Drug | Nivolumab + Ipilimumab + Chemotherapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 18 months
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.
2 secondary outcomes
Overall Survival (OS)
Time frame: Up to 24 months
Health-Related Quality of Life
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves prospectively collected clinical and patient-reported data obtained as part of routine clinical care, and data sharing was not included in the original study protocol or informed consent. Any data use will be limited to the approved analyses within the study framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Osman Sutcuoglu, MD contact
Ozan Yazıcı, MD study chair
Gazi University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonsmall Cell Lung Cancer, Stage IV and Metastatic Nonsmall Cell Lung Cancer, run by Gazi University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orhun Akdogan, MD (+905375831594, orhun.akdogan@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.