Lung Cancer (NSCLC)
Conditions
Brief summary
A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
Interventions
DRUGTislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group
Tislelizumab 400 mg iv, q6w, for up to 1 year; patients are permitted to receive concurrent adjuvant platinum-based doublet chemotherapy (q3w, up to 4 cycles) starting from the first dose of tislelizumab; during concurrent chemotherapy, a tislelizumab dosage of 200 mg iv, q3w is allowed.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year disease-free survival rate, 2y-DFS rate | From the start of randomization to two years later |
Secondary
| Measure | Time frame |
|---|---|
| disease-free survival, DFS | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| overall survival, OS | From date of randomization until the date of death from any cause, assessed up to 60 months |
| Number of Participants with Adverse Events as Assessed by CTCAE v5.0 | From enrollment to the end of systemic anti-tumor treatment at 30 days (90 days for recording irAE ) |
Countries
China
Contacts
CONTACTFengwei Tan
Outcome results
None listed