About this trial
A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
Eligibility criteria
Qualifiers
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)).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group
Treatment groups
Locations
1Sponsors and collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor