Actively Recruiting
Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-03-09
108
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
CONDITIONS
Official Title
Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent and agree to study requirements and assessments
- Age 18 years or older
- Histologically confirmed stage I non-small cell lung cancer, tumor size between 2 cm and 4 cm
- Postoperative pathology showing at least one high-risk factor: visceral pleural invasion, lymphovascular invasion, spread through air spaces (STAS), poorly differentiated status, or high-grade invasive adenocarcinoma (≥20% high-grade structures including solid, micropapillary, or complex glands)
- ECOG performance status of 0 or 1
- PD-L1 expression of 1% or higher
- No sensitive mutations in EGFR or ALK
- Complete tumor resection (R0)
- Within 8 weeks after surgery and fully recovered from operation
- Adequate organ function
You will not qualify if you...
- Any prior treatment for current lung cancer, including radiotherapy, chemotherapy, immunotherapy, targeted therapy, or anti-angiogenesis therapy
- Previous chest radiotherapy
- Diagnosis of large-cell neuroendocrine carcinoma or mixed subtype NSCLC with small-cell components
- Presence of EGFR or ALK sensitive mutations
- Underwent segmentectomy or wedge resection only
- Tumors involving main bronchi or with obstructive pneumonia/atelectasis
- Active or relapsing autoimmune disease
- History or current active interstitial lung disease or radiation pneumonitis requiring hormone therapy
- Use of systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressants within 14 days before randomization
- Use of other systemic immunomodulators within 4 weeks before first dose
- Use of herbal cancer treatments within 14 days before study
- Receipt or planned receipt of live/attenuated vaccines within 4 weeks before enrollment or within 5 months after last study dose
- Significant diseases or conditions affecting organ or system function
- Severe chronic or active infections needing systemic therapy within 14 days before first dose
- Known HIV infection
- History of allogeneic stem-cell or organ transplant
- Active malignancy within 2 years prior to enrollment, except specific cured cancers
- Conditions or substance abuse that could interfere with treatment or study outcomes
- Pregnant or breastfeeding women, or men or women planning to conceive during the study
- Participation in another interventional clinical study (except observational or follow-up phases)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
F
Fengwei Tan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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