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

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 Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Tislelizumab Injection

• Study Type: Interventional
• Enrollment (Estimated): 21
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Benxia Zhang, PhD; Phone Number: 86（028）85421606; Email: 951005569@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Drug: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Proportion of subjects with the best overall response (BOR)	Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS is the time from the date of randomization or first dosing date to death due to any cause.	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).	Up to approximately 2 years
DOR	DOR is the time between the first observed tumor responseto disease progression or relapse based on RECIST Version 1.1	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	Up to approximately 2 years

Collaborators and Investigators

• Sponsor: Sichuan University
• Investigators: Principal Investigator: Yongsheng Wang, West China Hospital, Sichuan University, Chengdu, Sichuan

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Tislelizumab
• Other Study ID Numbers: CM310_IIS_NSCLC08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No