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

A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC

This trial tests whether giving the immunotherapy drug tislelizumab for up to one year after complete surgery helps people with high-risk stage I non-small cell lung cancer whose tumors express PD-L1.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: tislelizumab, chemotherapy, immunotherapy, radiation, prednisone
• Locations: 1 site (Beijing)
• Trial ID: NCT07120282 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with completely resected stage I NSCLC (tumor 2–4 cm) who have at least one high‑risk pathological feature, PD‑L1 ≥1%, no EGFR/ALK sensitizing mutations, ECOG 0–1, and are within eight weeks of surgery.

Not a fit: Patients with EGFR or ALK sensitizing mutations, PD‑L1 <1%, incomplete resection, prior treatment for the current lung cancer, poor performance status, or significant organ dysfunction are unlikely to be eligible or benefit from this approach.

Why it matters

Potential benefit: If successful, adjuvant tislelizumab could lower recurrence risk after surgery and improve long-term outcomes for patients with high-risk stage I NSCLC.

How similar studies have performed: Other adjuvant PD‑1/PD‑L1 programs (for example atezolizumab and pembrolizumab in higher-stage NSCLC) have shown disease‑free survival benefits, supporting adjuvant immunotherapy though data specifically in high‑risk stage I remain limited.

Eligibility criteria

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 this trial is running

Beijing

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

Study contacts

• Study coordinator: Fengwei Tan

Conditions Lung Cancer