Immunotherapy after surgery may keep early lung cancer at bay
NCT ID NCT07120282
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the immunotherapy drug tislelizumab after surgery can help prevent lung cancer from coming back in people with high-risk stage I non-small cell lung cancer. About 108 adults whose tumors are 2–4 cm and have certain high-risk features will receive either tislelizumab or a placebo. The main goal is to see if the drug improves the number of patients who remain cancer-free two years after treatment.
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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 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2030
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: * Able to provide written informed consent form (ICF) and agree to follow study requirements and assessment schedule. * Aged 18 years or older. * Histologically confirmed stage I non - small cell lung cancer (AJCC 9th edition), with tumor size 2cm \<= T \<=4cm. * Postoperative pathological report shows at least one high-risk factor (visceral pleural invasion, lymphovascular invasion, STAS, poorly differentiated status, high-grade invasive adenocarcinoma (any structure + high grade structure \>=20%, including solid, micropapillary, or complex glands)). * ECOG performance status 0 or 1. * PD-L1 expression \>=1%. * No EGFR/ALK sensitive mutations. * Achieved complete resection (R0) . * Within 8 weeks after surgery, with full recovery from operation. * Adequate organ function. Exclusion Criteria: * Any previous treatment for current lung cancer, including radiotherapy and systemic anti-tumour therapies (chemotherapy, immunotherapy, targeted therapy, anti-angiogenesis therapy, etc.). * Prior chest radiotherapy (including lung, oesophageal, mediastinal, or breast cancer). * Patients with large - cell neuroendocrine carcinoma (LCNEC) or mixed - subtype non - small - cell lung cancer with small - cell components. * With EGFR/ALK sensitive mutations. * Underwent segmentectomy or wedge resection only. * Tumours involving main bronchi, or with obstructive pneumonia/atelectasis (partial or whole lung). * Active autoimmune disease or history of relapsing autoimmune disease. * History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis needing hormone therapy, or current active interstitial lung disease, or on relevant treatment/intervention. * Any condition needing systemic corticosteroid (\> 10 mg/d prednisone or equivalent) or other immunosuppressant within 14 days before randomisation * Used other approved systemic immunomodulators (interferon, interleukin - 2, tumour necrosis factor, thymopentin, thymosin α1, etc.) within 4 weeks before first dose. * Herbs used for cancer control within 14 days before first study * Live/attenuated vaccine receipt within 4 weeks before enrollment, or plan to receive during study or within 5 months after last tislelizumab dose. * History of significant disease or conditions affecting organ/system function, per investigator's judgment. * Severe chronic/active infection needing systemic antibacterial, antifungal, or antiviral therapy (e.g., tuberculosis) within 14 days before first study-drug dose. ·Known HIV infection. * Allogeneic stem - cell/organ transplant history. * Active malignancy within 2 years before enrollment, except the specific cancer studied and locally recurrent cancers cured (e.g., excised basal/squamous - cell skin cancer, superficial bladder cancer, cervical/ breast carcinoma in situ). * Specific conditions and/or alcohol/drug abuse or dependence that may hinder drug administration, affect outcome interpretation, or increase complication risks. * Pregnant/breastfeeding women, or men/women planning to conceive during the study. * Participation in another interventional clinical study (except observational studies or follow-up phases).
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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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Chinese Academy of Medical Sciences Cancer Hospital
RECRUITINGBeijing, China
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Other studies related to the condition(s) this trial covers.
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- Can one small incision replace multiple for lung cancer surgery?
- Could lung fungi hold clues to Cancer's behavior?