Adjuvant tislelizumab after surgery for high-risk stage I non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, multicenter phase 2 trial that gives adjuvant tislelizumab 400 mg IV every 6 weeks for up to one year to patients after complete resection of high-risk stage I NSCLC. Eligible patients have tumors 2–4 cm with at least one high‑risk pathological feature, PD‑L1 ≥1%, no EGFR or ALK sensitizing mutations, and ECOG 0–1. Patients are enrolled within eight weeks of surgery and must have recovered from the operation with adequate organ function. The trial compares recurrence and safety outcomes versus the control arm to determine whether adjuvant immunotherapy reduces relapse risk in this early-stage, higher-risk group.

Why it matters

Who can join: the full rules

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).

Where it's running

• Chinese Academy of Medical Sciences Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Fengwei Tan
• Email: tanfengwei@126.com
• Phone: +86 134 3945 7872

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.