Real-World data reveals how immunotherapy combo performs against lung cancer
NCT ID NCT07526961
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked back at medical records of 240 adults in Poland who received a combination of two immunotherapy drugs (nivolumab and ipilimumab) plus chemotherapy as their first treatment for advanced non-small cell lung cancer. The goal was to see how well the treatment worked in everyday hospital practice, not just in strict clinical trials. Researchers measured things like tumor shrinkage, how long patients lived, and what treatments they needed next.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Nivolumab + Ipilimumab + Chemotherapy
- What this could lead to
- If successful, this could show how well this drug combination works outside of controlled trials, helping doctors make better treatment decisions for advanced lung cancer.
- What could go wrong
- This is a retrospective chart review, not a controlled experiment, so results may be influenced by missing data or patient selection. It cannot prove cause and effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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240 people
The number who actually took part.
- Started
-
Dec 2025
- Finished
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Jan 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adults with inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 tumor proportion score \<50% treated with first-line nivolumab plus ipilimumab plus chemotherapy in participating hospitals in Poland under the Polish Drug Program.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults aged 18 years or older * Prescribed first-line nivolumab plus ipilimumab plus chemotherapy for non-small cell lung cancer between 01 January 2023 and 31 December 2023 in the Polish Drug Program * Diagnosis of inoperable locally advanced or metastatic non-small cell lung cancer with programmed death-ligand 1 tumor proportion score \<50% * Eastern Cooperative Oncology Group performance status 0 to 1 * At least one measurable lesion or a countable number of non-measurable lesions * Absence of activating mutations in the epidermal growth factor receptor (EGFR) gene or rearrangements in the anaplastic lymphoma kinase (ALK) gene and ROS1 gene * Absence of comorbid conditions that were not adequately controlled with pharmacological therapy and that, in the opinion of the treating physician, could compromise the safe administration of the study treatment * Absence of active autoimmune disease, except type 1 diabetes, hypothyroidism, psoriasis, or vitiligo * Hematopoietic function allowing treatment according to the current Summary of Product Characteristics (SmPC) * Absence of contraindications to nivolumab or ipilimumab according to the SmPC * Treatment history and response available for chart abstraction from treatment initiation through death or study end in living patients * Participants with central nervous system metastases may be included if they had no neurological symptoms, had at least stable disease after local treatment, and did not require chronic immunosuppressive doses of glucocorticoids Exclusion Criteria: • Participants will be excluded from analysis if any of the following criteria are met: * Confirmed disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, unless treatment was continued following local ablative therapy in cases of oligoprogression (including central nervous system lesions). * Clinically significant deterioration without radiological evidence of disease progression. * Unacceptable or life-threatening toxicity, including any toxicity requiring treatment discontinuation as per the product's SmPC. * Clinically relevant hypersensitivity to the study drug or its components. * Decline in performance status to Eastern Cooperative Oncology Group (ECOG) grade 3 or 4. * Treatment interruption due to adverse events exceeding 12 weeks. * Significant deterioration in quality of life, as documented in medical records. * Withdrawal of consent for continued treatment or participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Wielkopolska Center of Pulmonology and Thoracic Surgery of Eugenia and Janusz Zeyland
Poznan, Poland
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Other studies related to the condition(s) this trial covers.
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