Tests imzokitug with pumitamig and chemotherapy for advanced lung cancer
Tests imzokitug added to pumitamig and chemotherapy in adults with advanced lung cancer.
Plain-language title generated from the registry record
Registry title: A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Key facts
- Where
- Cologne, Frankfurt Am Main, Halle (saale), Homburg, Marburg, and Stuttgart, GermanySee the 6 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage IV or recurrent non-small cell lung cancer who have not yet had drug treatment for advanced disease.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Stage IV non-small cell lung cancer (squamous or non-squamous) or recurrent disease that cannot be removed by surgery. The cancer must be measurable on scans.
- Earlier treatment
- No earlier systemic anti-cancer therapy as primary treatment for advanced or metastatic disease. No earlier immuno-oncology therapy.
- Biomarker or test result
- No known gene change for which an approved first-line targeted therapy exists. A tumour tissue sample taken within 5 months before enrollment must be provided.
Main reasons for not taking part
- Gene change (AGA) for which an approved first-line targeted therapy is indicated
- Earlier immuno-oncology therapy
- Brain or spinal cord (CNS) metastases that have not been treated
- Performance status (ECOG) other than 0 or 1
Read by machine on 9 November 2026.
Where in Germany
- Kliniken der Stadt Koeln gGmbHCologne, GermanyNot yet recruiting
- Goethe University FrankfurtFrankfurt Am Main, GermanyNot yet recruiting
- Martha-Maria Krankenhaus Halle-Doelau gGmbHHalle (saale), GermanyNot yet recruiting
- Universitaet Des SaarlandesHomburg, GermanyNot yet recruiting
- Universitaetsklinikum Giessen und Marburg GmbHMarburg, GermanyNot yet recruiting
- Robert Bosch Gesellschaft fuer medizinische Forschung mbHStuttgart, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07680764EU 2026-525170-19-00
- Record updated
- 23 October 2026
- Original description
The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)Read full original descriptionShow less
A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Inclusion: Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition; Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease; Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site; Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1; Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Exclusion: Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated; Participants must not have prior treatment with immuno-oncology therapies; Participants must not have untreated central nervous system (CNS) metastases; Other protocol-defined Inclusion/Exclusion criteria apply.