Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC (NCT07120282) | Clinical Trial Compass
RecruitingPhase 2
Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
China108 participantsStarted 2025-10-28
Plain-language summary
A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
2 year disease-free survival rate, 2y-DFS rate
Timeframe: From the start of randomization to two years later
Trial details
NCT IDNCT07120282
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences