An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer

NCT ID: NCT06883552

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-10-01

Brief 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.

Conditions

Lung Cancer (NSCLC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stapokibart Injection in Combination with Tislelizumab Injection in Patients with NSCLC

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).

Group Type: EXPERIMENTAL

Tislelizumab Injection

Intervention Type: DRUG

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).

Interventions

Tislelizumab Injection

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

• 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).
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sichuan University

OTHER

Sponsor Role: lead

Responsible Party

Yongsheng Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongsheng Wang

Role: PRINCIPAL_INVESTIGATOR

West China Hospital, Sichuan University, Chengdu, Sichuan

Central Contacts

Benxia Zhang, PhD

Role: CONTACT

951005569@qq.com

86（028）85421606

Other Identifiers

CM310_IIS_NSCLC08

Identifier Type: -

Identifier Source: org_study_id