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

NCT07120282 | Recruiting Phase 2

• 2 other identifiers: NCC5190ChiCTR2500103192
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• 2 year disease-free survival rate, 2y-DFS rate

  From the start of randomization to two years later

Secondary Outcomes (3)

• 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 )

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Drug: Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group

Control group

NO INTERVENTION

Patients are permitted to receive postoperative adjuvant platinum - based doublet chemotherapy (q3w, up to 4 cycles).

Interventions

Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group DRUG

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Chinese Academy of Medical Sciences Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; 6-pyruvoyltetrahydropterin synthase

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Fengwei Tan

CONTACT

+86 134 3945 7872; tanfengwei@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 13, 2025
• Study Start: October 28, 2025
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 9, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)