Could chemo plus immunotherapy double the punch against tough lung cancers?
NCT ID NCT07715396
First seen Jul 20, 2026 · Last updated Jul 23, 2026 · Updated 3 times
Summary
This phase 3 trial investigates whether adding platinum-based chemotherapy to the immunotherapy drug tislelizumab helps people with a specific type of advanced lung cancer live longer without the disease worsening. Participants have non-small cell lung cancer that has spread, shows high levels of PD-L1 (a protein that helps cancer hide from the immune system), and includes at least one large tumor. The study compares the combination therapy against tislelizumab alone and also against another immunotherapy, pembrolizumab, to see which approach works best.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab, an immunotherapy drug, combined with platinum-based chemotherapy
- What this could lead to
- If successful, this could establish a more effective first-line treatment for people with advanced lung cancer that has high PD-L1 expression and large tumors.
- What could go wrong
- Adding chemotherapy increases side effects, and it is not yet known whether the combination improves survival more than immunotherapy alone in this specific group.
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.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 230 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- 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: 1. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study 2. Histologically confirmed and treatment-naïve non-small cell lung cancer UICC 9th stage IV 3. PD-L1 ≥ 50% 4. 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 5. Measurable disease according to RECIST v1.1 6. No actionable genomic alterations (AGA) qualifying for targeted first-line treatment 7. Eligible for platinum-based chemoimmunotherapy 8. Age ≥18 years 9. 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. 10. 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 Criteria: 1. 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 2. 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 3. Concurrent malignancy other than NSCLC requiring active treatment 4. 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 5. 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) 6. 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) 7. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities 8. 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
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Frankfurt
Frankfurt, Germany
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