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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Gazi University Academic / other |
| Drugs / interventions | pembrolizumab, nivolumab, ipilimumab, chemotherapy, immunotherapy |
| Locations | 2 sites (Ankara and 1 other locations) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | August 2027 |
| Study ends | February 2028 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT07394062 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
- Study coordinator: Orhun Akdogan, MD
- Email: orhun.akdogan@gazi.edu.tr
- Phone: +905375831594
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
First-Line Nivolumab plus Ipilimumab in unresectable hepatocellular carcinoma
This study tests whether the combination of nivolumab and ipilimumab is safe and effective for adults with unresectable liver cancer in real-world care in Japan.
-
30-minute cycling immediately before nivolumab and ipilimumab for metastatic melanoma
This trial will test whether a 30-minute cycling session immediately before nivolumab plus ipilimumab boosts immune activity and improves outcomes for people with metastatic melanoma.
-
VSV-IFNβ-NIS plus ipilimumab and nivolumab for advanced or metastatic clear cell renal cell carcinoma
This trial adds a virus-based therapy (VSV-IFNβ-NIS) to standard immunotherapy (ipilimumab and nivolumab) to see if it helps people with advanced or metastatic clear cell renal cell cancer.
-
Using ctDNA to decide whether to add ipilimumab for people on nivolumab and relatlimab
This tests whether using a ctDNA blood test to guide adding ipilimumab for adults with advanced or metastatic melanoma on nivolumab and relatlimab leads to longer progression-free survival.
-
Neoadjuvant immunotherapy for high-risk eye melanoma
This trial tests whether giving nivolumab and ipilimumab before surgery is safe and feasible for adults with high-risk uveal melanoma.
-
Y90 liver radiation plus immunotherapy and targeted drug for unresectable liver cancer
This test will see if adding Y90 liver radiation to nivolumab, ipilimumab, and lenvatinib helps people with unresectable hepatocellular carcinoma live longer and have better tumor responses.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.