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

NCT06883552 | Not Yet Recruiting Phase 2

• 1 other identifier: CM310_IIS_NSCLC08
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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)

Outcome Measures

Primary Outcomes (1)

• ORR

  Proportion of subjects with the best overall response (BOR)

  Up to approximately 2 years

Secondary Outcomes (4)

• DOR

  Up to approximately 2 years

• DCR

  Up to approximately 2 years

• PFS

  Up to approximately 2 years

• OS

  Up to approximately 2 years

Study Arms (1)

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).

Drug: Tislelizumab Injection

Interventions

Tislelizumab Injection 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).

Stapokibart Injection in Combination with Tislelizumab Injection in Patients with NSCLC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Yongsheng Wang

  West China Hospital, Sichuan University, Chengdu, Sichuan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benxia Zhang, PhD

CONTACT

86（028）85421606; 951005569@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share