New combo before lung surgery shows promise in early trial
NCT ID NCT07050056
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial is testing whether giving the immunotherapy drug tislelizumab along with radiation therapy before surgery can help eliminate more cancer in people with resectable non-small cell lung cancer (NSCLC). About 20 participants will receive the combination, then have surgery to remove their tumor. The main goal is to see how many patients have no cancer left in the removed tissue (complete pathological response).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tislelizumab (a drug that helps the immune system fight cancer) and radiation therapy
- What this could lead to
- If successful, this combination could become a new standard approach to shrink tumors before surgery, potentially improving survival for people with early-stage lung cancer.
- What could go wrong
- This is a small, early-phase trial with only 20 participants, so results may not apply to everyone. The combination of immunotherapy and radiation can cause serious side effects like lung inflammation or immune reactions.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 2027
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 to 70 years
- 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: * Fully understand the study and voluntarily sign the informed consent form (ICF); * Aged 18-70 years, regardless of gender; * Previously untreated, histologically confirmed resectable stage IB-IIIA NSCLC (AJCC 9th edition staging); * At least one measurable lesion per RECIST v1.1 criteria; * Willing to provide PD-L1 immunohistochemistry slides and corresponding pathology reports for biomarker evaluation; * Presence of lesions suitable for radiotherapy as assessed by the study team; * ECOG performance status of 0-1; * Adequate organ function; * Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures; * Sufficient pulmonary function to tolerate planned lung resection surgery, as assessed by a surgeon; * Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to the first dose. Both female participants of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective contraception during the study and for 180 days after the last dose of the study drug. Exclusion Criteria: * Presence of locally advanced unresectable or metastatic disease; * NSCLC involving the superior sulcus, large cell neuroendocrine carcinoma (LCNEC), or sarcomatoid tumors; * Participants with known EGFR mutations or ALK translocations (non-squamous NSCLC subjects must have confirmed EGFR/ALK mutation status); * Prior systemic anticancer therapy for early-stage NSCLC, including investigational drugs; Contraindications to radiotherapy or inability to undergo radiotherapy; * History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease requiring steroid treatment; * Known active tuberculosis (TB) history; Known active infection requiring systemic therapy; Any known or suspected autoimmune disease or immunodeficiency; * Active hepatitis B infection; Administration of live vaccines within 30 days before the first dose; * Grade ≥2 peripheral neuropathy; * Prior treatment with PD-1/PD-L1 inhibitors or drugs targeting other T-cell receptors (e.g., CTLA-4, OX-40, etc.); * History of severe hypersensitivity to monoclonal antibodies; * Severe or uncontrolled underlying medical conditions; * Any condition that, in the investigator's judgment, may confound study results, interfere with the subject's participation, or compromise the subject's best interest in the study.
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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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Jiangsu Northern People Hospital
RECRUITINGYangzhou, Jiangsu, 225001, China
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