Lung Cancer (NSCLC)Phase 2NCT06883552
An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer
A Phase 2 study testing Tislelizumab Injection in people with Lung Cancer (NSCLC), run by Sichuan University.
Trial summary
This is a single-arm study evaluating the efficacy and safety of Stapokibart Injection in combination with Tislelizumab Injection in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Tislelizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of comprehending the nature of the study and voluntarily signing the Informed Consent Form (ICF).
- Aged ≥18 and ≤75 years, regardless of gender.
- Patients with driver gene-negative NSCLC who have failed first-line standard therapy and are ineligible for second-line therapy or alternative chemotherapy regimens.
- Treatment failure definition: Disease progression during or after treatment. Changes in therapy due to drug intolerance are not considered treatment failure.
- At least one measurable tumor lesion per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Investigator-assessed life expectancy ≥3 months.
- Agreement to undergo tumor tissue biopsy prior to initial study treatment and during therapy when clinically feasible.
- Adequate organ function confirmed by laboratory tests within 7 days prior to first dose:
- Bone marrow function (no transfusion/growth factors within 2 weeks pre-screening):
- Absolute neutrophil count ≥1.5×10⁹/L;Platelet count ≥75×10⁹/L;Hemoglobin ≥90 g/L Hepatic function:Total bilirubin ≤1.5×ULN (≤3×ULN with liver metastases); AST/ALT ≤2.5×ULN (≤5×ULN with liver metastases);Albumin ≥28 g/L Renal function:Serum creatinine ≤1.5×ULN OR creatinine clearance ≥50 mL/min. Coagulation:INR and APTT ≤1.5×ULN. Chronic HBV-infected subjects must have HBV-DNA <1,000 IU/mL and commit to antiviral therapy throughout the study.
- Prior treatment-related toxicities resolved to ≤Grade 1 (CTCAE v5.0) or stabilized (excluding alopecia/pigmentation).
- Subjects of reproductive potential must use highly effective contraception from ICF signing until 6 months post-last dose.
- Ability to communicate effectively with investigators and comply with protocol-specified follow-up.
Who cannot join
- Received cytotoxic chemotherapy or Chinese herbal medicines with antitumor activity within 14 days prior to the first dose.
- Received radiotherapy, biologic therapy (e.g., cancer vaccines, cytokines, growth factors), or other immunotherapy (excluding PD-1/PD-L1 inhibitors) within 28 days or 5 half-lives (whichever is shorter) before the first dose.
- Note: For palliative radiotherapy (≤14 days total duration) targeting non-CNS lesions, a ≥7-day washout period is required prior to the first dose.
- Received anti-interleukin-4 receptor alpha (IL-4Rα) monoclonal antibodies, anti-IgE monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) before the first dose.
- Received live/attenuated vaccines within 12 weeks prior to the first dose or plans to receive such vaccines during the study.
- History of hypersensitivity to anti-IL-4Rα monoclonal antibodies, Stapokibart Injection, or other protein-based therapeutics (e.g., vaccines, immunoglobulins).
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- Grade ≥3, severe, or life-threatening immune-related adverse events (irAEs) during prior immunotherapy (excluding Grade 3 endocrine AEs manageable with replacement therapy), or unresolved Grade 1-2 irAEs after treatment discontinuation.
- Clinically significant cardiovascular/cerebrovascular diseases, including:
- Major events (e.g., congestive heart failure, acute MI, unstable angina, stroke, TIA, DVT/PE) within 6 months before the first dose.
- QTcF >480 msec.
- LVEF <50% by echocardiography.
- NYHA Class ≥2.
- Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg; rescreening permitted if controlled post-intervention).
- Other cardiovascular conditions deemed high-risk by investigators.
- Planned major surgery during the study period.
- Active CNS metastases. Note: Treated brain metastases may be eligible if radiographically/ clinically stable for ≥14 days before the first dose, confirmed by repeat imaging (≥4-week interval) during screening.
- Uncontrolled pleural, peritoneal, or pericardial effusion (investigator-assessed).
- Active Mycobacterium tuberculosis infection (i.e., active tuberculosis).
- HCV Ab-positive with detectable HCV RNA.
- HIV infection or positive HIV antibody test during screening.
- History of other malignancies within 5 years (exceptions: cured basal/squamous cell carcinoma, cervical/breast ductal carcinoma in situ).
- Active autoimmune disease requiring systemic treatment (e.g., immunomodulators, corticosteroids) within 2 years.
- Note: Replacement therapy (e.g., thyroxine, insulin) is permitted.
- Prior organ or allogeneic hematopoietic stem cell transplantation.
- Pregnancy or lactation.
- Any condition that may confound study results, impair compliance, or jeopardize subject safety (investigator-determined).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is a single-arm study evaluating the efficacy and safety of Stapokibart Injection in combination with Tislelizumab Injection in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Tislelizumab Injection
- 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 InjectionDrug
During treatment cycles 1-18, Tislelizumab Injection will be administered in combination with Tislelizumab Injection. From cycle 19 onward, treatment will continue with Tislelizumab Injection monotherapy. The specific regimen is as follows: Tislelizumab Injection: 600 mg (initial dose) - 300 mg (subsequent doses), subcutaneously (SC), every 3 weeks (Q3W), for a total of 18 doses (1 year). Tislelizumab: 200 mg, intravenously (IV), every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| Stapokibart Injection in Combination with Tislelizumab Injection in Patients with NSCLC | Experimental | During treatment cycles 1-18, Tislelizumab Injection will be administered in combination with Tislelizumab Injection. From cycle 19 onward, treatment will continue with Tislelizumab Injection monotherapy. The specific regimen is as follows:
Tislelizumab Injection: 600 mg (initial dose) - 300 mg (subsequent doses), subcutaneously (SC), every 3 weeks (Q3W), for a total of 18 doses (1 year).
Tislelizumab: 200 mg, intravenously (IV), every 3 weeks (Q3W). Receives: Drug: Tislelizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Proportion of subjects with the best overall response (BOR)
Measured: Up to approximately 2 years
Secondary outcomes (4)
DOR
DOR is the time between the first observed tumor responseto disease progression or relapse based on RECIST Version 1.1
Measured: Up to approximately 2 years
DCR
DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1
Measured: Up to approximately 2 years
PFS
PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Measured: Up to approximately 2 years
OS
OS is the time from the date of randomization or first dosing date to death due to any cause.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (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 Sichuan UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsheng Wang, Sichuan University
- Investigators
- Yongsheng Wang, Principal investigator, West China Hospital, Sichuan University, Chengdu, Sichuan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883552
- Sponsor's protocol ID
- CM310_IIS_NSCLC08
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06883552
- Acronym / sponsor ID
- CM310_IIS_NSCLC08
- Conditions
- Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 19 Mar 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.
This is a single-arm study evaluating the efficacy and safety of Stapokibart Injection in combination with Tislelizumab Injection in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stapokibart Injection in Combination with Tislelizumab Injection in Patients with NSCLC | Experimental | Drug: Tislelizumab InjectionDuring treatment cycles 1-18, Tislelizumab Injection will be administered in combination with Tislelizumab Injection. From cycle 19 onward, treatment will continue with Tislelizumab Injection monotherapy. The specific regimen is as follows: Tislelizumab Injection: 600 mg (initial dose) - 300 mg (subsequent doses), subcutaneously (SC), every 3 weeks (Q3W), for a total of 18 doses (1 year). Tislelizumab: 200 mg, intravenously (IV), every 3 weeks (Q3W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Capable of comprehending the nature of the study and voluntarily signing the Informed Consent Form (ICF).
- Aged ≥18 and ≤75 years, regardless of gender.
- Patients with driver gene-negative NSCLC who have failed first-line standard therapy and are ineligible for second-line therapy or alternative chemotherapy regimens.
- Treatment failure definition: Disease progression during or after treatment. Changes in therapy due to drug intolerance are not considered treatment failure.
- At least one measurable tumor lesion per RECIST v1.1.
Key exclusion criteria (26 listed)
- Received cytotoxic chemotherapy or Chinese herbal medicines with antitumor activity within 14 days prior to the first dose.
- Received radiotherapy, biologic therapy (e.g., cancer vaccines, cytokines, growth factors), or other immunotherapy (excluding PD-1/PD-L1 inhibitors) within 28 days or 5 half-lives (whichever is shorter) before the first dose.
- Note: For palliative radiotherapy (≤14 days total duration) targeting non-CNS lesions, a ≥7-day washout period is required prior to the first dose.
- Received anti-interleukin-4 receptor alpha (IL-4Rα) monoclonal antibodies, anti-IgE monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) before the first dose.
- Received live/attenuated vaccines within 12 weeks prior to the first dose or plans to receive such vaccines during the study.
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 InjectionDuring treatment cycles 1-18, Tislelizumab Injection will be administered in combination with Tislelizumab Injection. From cycle 19 onward, treatment will continue with Tislelizumab Injection monotherapy. The specific regimen is as follows: Tislelizumab Injection: 600 mg (initial dose) - 300 mg (subsequent doses), subcutaneously (SC), every 3 weeks (Q3W), for a total of 18 doses (1 year). Tislelizumab: 200 mg, intravenously (IV), every 3 weeks (Q3W). | Drug | Stapokibart Injection in Combination with Tislelizumab Injection in Patients with NSCLC |
Primary outcome
ORR
Time frame: Up to approximately 2 years
Proportion of subjects with the best overall response (BOR)
4 secondary outcomes
DOR
Time frame: Up to approximately 2 years
DCR
Time frame: Up to approximately 2 years
PFS
Time frame: Up to approximately 2 years
OS
Time frame: Up to approximately 2 years
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 19 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
Yongsheng Wang principal investigator
West China Hospital, Sichuan University, Chengdu, Sichuan
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab Injection in people with Lung Cancer (NSCLC), run by Sichuan University.
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 14 inclusion and 26 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: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Benxia Zhang, PhD (86（028）85421606, 951005569@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Up to approximately 2 years). 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 19 Mar 2025.