Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC

Official title

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

Overview

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

Interventions

• Drug Tislelizumab 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.

Primary outcome measures

• 2 year disease-free survival rate, 2y-DFS rate [Time frame: From the start of randomization to two years later]

Secondary outcome measures (3)

• disease-free survival, DFS [Time frame: 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 [Time frame: 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 [Time frame: From enrollment to the end of systemic anti-tumor treatment at 30 days (90 days for recording irAE )]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Chinese Academy of Medical Sciences Cancer Hospital — Beijing

Identifiers

NCT: NCT07120282 · NCC5190 · ChiCTR2500103192

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)
• ChiCTR ChiCTR2500103192 (Chinese Clinical Trial Registry)

View this study on ClinicalTrials.gov ↗