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Non-small Cell Lung Cancer MetastaticPhase 3High FiveNCT07715396

Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden

A Phase 3 study testing Tislelizumab, Tislelizumab Combined With Chemotherapy and Pembrolizumab in people with Non-small Cell Lung Cancer Metastatic, run by AIO-Studien-gGmbH at 1 site in Germany.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer Metastatic
What is being tested?
Tislelizumab, Tislelizumab Combined With Chemotherapy and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 siteGermany
Study dates
30 Oct 2026to 30 Oct 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
  • 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
  • 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
  • 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)
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  • Concurrent yellow fever vaccination
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gordana Bothe contact

+4930814534443

gordana.bothe@aio-studien-ggmbh.de

Germany1 site

  • University of Frankfurt

    Frankfurt

    Sophie Ambrosius, +49 69 6301 5677, s.ambrosius@med.uni-frankfurt.de

    Sophie Ambrosius

Other trials in Germany

About this study

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 the detailed description

This is a randomized, open-label, multicenter, phase III trial. Patients with squamous or non-squamous non-small-cell lung cancer (NSCLC) UICC 9th Stage IV, a high PD-L1 expression level (PD-L1 ≥ 50%) and a high tumor burden (baseline tumor size (BTS) ≥ 50 mm), eligible for 1st-line treatment with platinum and immunotherapy, will be enrolled in this trial. The patients will receive immuno-monotherapy (tislelizumab or pembrolizumab) or immunotherapy plus platinum-based doublet chemotherapy (squamous NSCLC: tislelizumab + carboplatin + (nab-) paclitaxel with tislelizumab maintenance; non-squamous NSCLC: tislelizumab + cis-/carboplatin + pemetrexed with tislelizumab maintenance) for a maximum of 24 months, with a subsequent follow-up phase until end of study (26 months after last patient in or until all patients have finished a 90-days safety follow-up) or preliminary termination or death. Standard of care tumor assessments will be performed and recorded according to RECIST version 1.1., at baseline/screening, throughout the treatment phase (initially after 6 weeks, thereafter each 12 ± 2 weeks), at end of treatment and during follow up.

Being tested
Tislelizumab, Tislelizumab Combined With Chemotherapy, Pembrolizumab
Keywords
Metastatic, Stage IV, NSCLC, High tumor burden, Immunotherapy, Platinum-based chemotherapy
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Tislelizumab monotherapy 200 mg i.v. q3w

  • Tislelizumab Combined With ChemotherapyDrug

    Non-squamous NSCLC: tislelizumab 200 mg i.v. + platinum-based chemotherapy (cisplatin 75 mg/m2 i.v. or carboplatin AUC 5-6 i.v.) + pemetrexed 500 mg/m2 i.v.; squamous NSCLC: tislelizumab 200 mg i.v. + carboplatin AUC 5-6 i.v. + (nab)paclitaxel (nab-paclitaxel 100 mg/m2 i.v., paclitaxel 175 or 200 mg/m2 i.v.

  • PembrolizumabDrug

    Pembrolizumab monotherapy 200 mg i.v. q3w

Study groups in NCT07715396
Study groupRoleWhat they receive
Immune-monotherapyActive comparatorTislelizumab monotherapy 200 mg i.v. q3w or pembrolizumab monotherapy 200 mg i.v. q3w or
Receives: Drug: Tislelizumab; Drug: Pembrolizumab
Tislelizumab + platinum-based doublet chemotherapyExperimentalNon-squamous NSCLC: tislelizumab 200 mg i.v. + platinum-based chemotherapy (cisplatin 75 mg/m2 i.v. or carboplatin AUC 5-6 i.v.) + pemetrexed 500 mg/m2 i.v.; squamous NSCLC: tislelizumab 200 mg i.v. + carboplatin AUC 5-6 i.v. + (nab)paclitaxel (nab-paclitaxel 100 mg/m2 i.v., paclitaxel 175 or 200 mg/m2 i.v.
Receives: Drug: Tislelizumab Combined With Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    time from randomization to the date of first objective disease progression (according to RECIST V1.1 as determined by blinded independent central review [BICR]) or death of any cause, whichever occurs first

    Measured: max. 50 months

Secondary outcomes (6)

  1. Overall survival

    Measured: max. 50 months

  2. Objective response rate

    rate of patients with complete response (CR) or partial response (PR) as best response, based on assessment according to RECIST1.1 by local investigator, as well as by BICR

    Measured: max. 50 months

  3. Duration of response

    time from first occurrence of CR or PR as best response to the date of first objective disease progression (according to RECIST V1.1 by local investigator, as well as by BICR) or death of any cause, whichever occurs first

    Measured: max. 50 months

  4. Disease control rate

    rate of patients with CR, PR or stable disease (SD) as best response, based on assessment according to RECIST1.1 by local investigator, as well as by BICR

    Measured: max. 50 months

  5. Progression-free survival according to RECIST V1.1 as determined by local investigator

    time from randomization to the date of first objective disease progression (according to RECIST V1.1 as determined by local investigator) or death of any cause, whichever occurs first

    Measured: max. 50 months

  6. Quality of life (FACT-L)

    Functional Assessment of Cancer Therapy-Lung Total score 0-136; higher scores indicate better quality of life

    Measured: max. 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Oct 2031 (estimated)
  4. Study completion30 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07715396
Sponsor's protocol ID
AIO-TRK/YMO-0425
Other IDs
2026-525497-18-00
Acronym
High Five
Status last verified
Oct 2026
First submitted
15 Jul 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tislelizumab, Tislelizumab Combined With Chemotherapy and Pembrolizumab in people with Non-small Cell Lung Cancer Metastatic, run by AIO-Studien-gGmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gordana Bothe (+4930814534443, gordana.bothe@aio-studien-ggmbh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: max. 50 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07715396.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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