Adding chemotherapy to immunotherapy for advanced lung cancer with high tumor burden
Tests adding platinum chemotherapy to tislelizumab in adults with advanced lung cancer.
Plain-language title generated from the registry record
Registry title: Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden
Key facts
- Where
- Berlin, Bremen, Dortmund, Dresden, Esslingen am Neckar, Frankfurt Am Main, Hemer, Homburg, Landshut, Munich, Regensburg, Saarbrücken, Wermelskirchen, Westerstede, Witten, and Wuppertal, GermanySee the 16 sites
- Phase
- Phase 3
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 non-small cell lung cancer, not yet treated, with high PD-L1 and a large tumour. It compares immunotherapy alone with immunotherapy plus platinum-based chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Stage IV non-small cell lung cancer confirmed by tissue test, with measurable disease. The longest diameter of the tumour or of at least one metastasis is 50mm or more. Treatment meant to remove all of the disease is not possible.
- Earlier treatment
- No earlier treatment for the cancer. Brain metastases can be allowed, but not while whole brain radiation therapy is still pending. After it, people can join 7 or more days later.
- Biomarker or test result
- PD-L1 of 50% or more. No gene change that could be treated with targeted first-line treatment.
Main reasons for not taking part
- Another cancer that needs active treatment
- An autoimmune disease that rules out the study drugs
- Steroid use above 10 mg/day of prednisone or equivalent
- Known allergy to the study drugs
- Pregnant or breast-feeding
Read by machine on 9 November 2026.
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
- Gesundheit Nord gGmbH Klinikverbund BremenBremen, GermanyNot yet recruiting
- St Johannes Hospital gGmbHDortmund, GermanyNot yet recruiting
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyNot yet recruiting
- Klinikum Esslingen GmbHEsslingen am Neckar, GermanyNot yet recruiting
- Universitaetsklinikum Frankfurt AöRFrankfurt Am Main, GermanyNot yet recruiting
- Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbHHemer, GermanyNot yet recruiting
- Universitaetsklinikum des Saarlandes AöRHomburg, GermanyNot yet recruiting
- LA-Regio Kliniken gKU AöR des Landkreises und der Stadt LandshutLandshut, GermanyNot yet recruiting
- LMU Klinikum Muenchen AöRMunich, GermanyNot yet recruiting
- Barmherzige Brueder gemeinnuetzige Krankenhaus GmbHRegensburg, GermanyNot yet recruiting
- Med. Statistik Saarbrücken - Studienbüro MVZ OnkologieSaarbrücken, GermanyNot yet recruiting
- KHOP Studien UG (haftungsbeschraenkt)Wermelskirchen, GermanyNot yet recruiting
- Medizinische Studiengesellschaft NORD-WEST GmbHWesterstede, GermanyNot yet recruiting
- St. Elisabeth Gruppe GmbH, Marien Hospital WittenWitten, GermanyNot yet recruiting
- Petrus-KrankenhausWuppertal, 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
- AIO-Studien-gGmbH
- Trial code
- NCT07715396EU 2026-525497-18-00
- Record updated
- 26 October 2026
- Original description
AIO-TRK/YMO-0425 (High Five) is a phase III, open-label randomized-controlled, multicenter study to evaluate the progression-free survival by the addition of platinum-based chemotherapy to immunotherapy (IO) compared to IO monotherapy in patients with PD-L1high mNSCLC featuring a high tumor burden.Read full original descriptionShow less
Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden
AIO-TRK/YMO-0425 (High Five) is a phase III, open-label randomized-controlled, multicenter study to evaluate the progression-free survival by the addition of platinum-based chemotherapy to immunotherapy (IO) compared to IO monotherapy in patients with PD-L1high mNSCLC featuring a high tumor burden.
Inclusion: Written informed consent obtained from subject and ability for subject to comply with the requirements of the study; Histologically confirmed and treatment-naïve non-small cell lung cancer UICC 9th stage IV; PD-L1 ≥ 50%; High Tumor Burden defined as the longest diameter of the tumor or at least one metastasis ≥ 50mm and no eligibility for a curative treatment approach; Measurable disease according to RECIST v1.1; No actionable genomic alterations (AGA) qualifying for targeted first-line treatment; Eligible for platinum-based chemoimmunotherapy; Age ≥18 years; Patients with brain metastases may be included, except when whole brain radiation therapy (WBRT) is pending. In such case, patients may be included 7 or more days after completion of WBRT; Female subjects of childbearing potential (FOCBP) should be using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not be breast-feeding prior to start of trial. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:; Postmenopausal, defined as at least 12 months with no menses without an alternative medical cause; a follicle stimulating hormone (FSH) level in the postmenopausal range for the institution may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient; have had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, at least 6 weeks prior to screening (Women with tubal ligation are still considered of child-bearing potential according to CTFG Guidance); have a congenital or acquired condition that prevents childbearing Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
Exclusion: Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study, or during the follow-up period of an interventional study; Concurrent malignancy other than NSCLC requiring active treatment; Current use of systemic corticosteroids that exceed 10 mg/day of prednisone or is equivalent medication within 3 days before the first dose of tislelizumab/pembrolizumab, except the following criterion:; steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication); Concurrent yellow fever vaccination; Presence of a condition, disease or abnormality that in the opinion of the Investigator would compromise the safety of the patient, the patient's ability to comply with the study procedures (e.g., dementia) or the quality of the data. Specifically, the presence of any preexisting autoimmune disease that prohibits dosing of IMP as per treatment modification guidelines in the current IB/SmPC; Has known hypersensitivity to the IMPs or to any component of the planned regimen, their metabolites, or formulation excipients, or any other contraindication to any component of the planned study regimen according to the tislelizumab IB and the relevant SmPCs; Female subjects who are pregnant or breast-feeding or patients of reproductive potential who are not employing a highly effective method of birth control (failure rate of less than 1% per year); Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities; Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts.