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RecruitingNCT07120282Updated Mar 9, 2026

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

A Phase 2 interventional study of Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group in Lung Cancer (NSCLC), sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 108 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    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.

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

  • No intervention
    Control group

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

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.

06

What researchers measure

Primary outcomes

  1. 2 year disease-free survival rate, 2y-DFS rate

    Time frame: From the start of randomization to two years later

Secondary outcomes

  1. 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

  2. overall survival, OS

    Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months

  3. 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 )

07

Study locations

1 of 1 sites recruiting
  • Chinese Academy of Medical Sciences Cancer Hospital
    Beijing, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07120282
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Responsible party
Zhijie Wang (Chief Physician, Cancer Institute and Hospital, Chinese Academy of Medical Sciences) — Principal investigator
First posted
Aug 13, 2025
Start date
Oct 28, 2025
Primary completion
Aug 15, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Mar 9, 2026

Study contacts

Fengwei Tan
Contact
tanfengwei@126.com
+86 134 3945 7872

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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