Lung Cancer (NSCLC)Phase 2NCT07120282
Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
A Phase 2 study testing Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group in people with Lung Cancer (NSCLC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2025to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
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- No EGFR/ALK sensitive mutations.
- Achieved complete resection (R0) .
- Within 8 weeks after surgery, with full recovery from operation.
- Adequate organ function.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences Cancer Hospital
Beijing
Tan, +86 134 3945 7872, tanfengwei@126.com
About this study
Official title: A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
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)
- Being tested
- Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 year disease-free survival rate, 2y-DFS rate
Measured: From the start of randomization to two years later
Secondary outcomes (3)
disease-free survival, DFS
Measured: 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
Measured: 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
Measured: From enrollment to the end of systemic anti-tumor treatment at 30 days (90 days for recording irAE )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start28 Oct 2025
- Primary completion15 Aug 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120282
- Sponsor's protocol ID
- NCC5190
- Other IDs
- ChiCTR2500103192
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
- ClinicalTrials.gov ID
- NCT07120282
- Acronym / sponsor ID
- NCC5190
- Conditions
- Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 15 Aug 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Adjuvant Tislelizumab in High-Risk Stage I NSCLC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention groupTislelizumab 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. |
| Control group | No intervention | –Patients are permitted to receive postoperative adjuvant platinum - based doublet chemotherapy (q3w, up to 4 cycles). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention groupTislelizumab 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 | Intervention group |
Primary outcome
2 year disease-free survival rate, 2y-DFS rate
Time frame: From the start of randomization to two years later
3 secondary outcomes
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 )
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab 400 mg iv, q6w, for up to 1 year for pts in intervention group in people with Lung Cancer (NSCLC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengwei Tan (+86 134 3945 7872, tanfengwei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 year disease-free survival rate, 2y-DFS rate (time frame: From the start of randomization to two years later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.