Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Comparing chemo‑immunotherapy options for metastatic NSCLC with PD‑L1 <50%

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%

Run by Gazi University · NCT07394062 · Data updated 2026-11-12

This project will see if two common first‑line chemo‑immunotherapy approaches give different survival and quality‑of‑life results for adults with metastatic NSCLC whose tumors have PD‑L1 under 50%.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorGazi University
Academic / other
Drugs / interventionspembrolizumab, nivolumab, ipilimumab, chemotherapy, immunotherapy
Locations2 sites (Ankara and 1 other locations)
StatusRecruiting
StartedFebruary 1, 2026
Main results expectedAugust 2027
Study endsFebruary 2028
Registry record updatedMay 18, 2026
Trial IDNCT07394062 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with histologically confirmed stage IV NSCLC, tumor PD‑L1 <50%, starting first‑line systemic treatment with either chemotherapy plus pembrolizumab or chemotherapy with nivolumab plus ipilimumab, and able to give informed consent.

Probably not a fit

Patients who have received prior systemic therapy for metastatic NSCLC, have another active cancer needing systemic treatment, cannot comply with routine follow‑up, or are treated outside the participating sites are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational cohort that follows adults with stage IV NSCLC and tumor PD‑L1 <50% treated in routine clinical practice. Two commonly used approaches—chemotherapy plus pembrolizumab, and chemotherapy combined with nivolumab plus ipilimumab—will be recorded based on treating physicians' choices without randomization. The main outcomes are progression‑free survival and overall survival measured from standard clinical and radiological follow‑up; health‑related quality of life will be collected with validated patient‑reported questionnaires. Exploratory analyses will examine associations between outcomes and patient factors such as biological age metrics and recent antibiotic exposure.

Why it matters

Potential benefit: If successful, the results could help doctors choose the chemo‑immunotherapy approach most likely to prolong life or preserve quality of life for patients with PD‑L1 <50% metastatic NSCLC.

How similar studies have gone: Randomized trials have shown benefit for pembrolizumab plus chemotherapy and for nivolumab‑ipilimumab combinations in various NSCLC populations, but direct real‑world head‑to‑head comparisons like this are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Ankara Etlik City Hospital
    Ankara, Turkey (Türkiye)
    Recruiting
  • Gazi University Faculty of Medicine, Department of Medical Oncology
    Ankara, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.