SYHX2011 in Combination With Carboplatin and Enlonstobart as First-Line Therapy for Squamous Non-Small Cell Lung Cancer

NCT07662811 | Not Yet Recruiting Phase 2

• 1 other identifier: CSPC-XBZ-LUNG-K01
• Study Type: interventional
• Target: 396
• Locations: 0 countries
• Sites: N/A

Brief Summary

Efficacy and Safety of SYHX2011 Combined with Carboplatin and Enlonstobart versus Nab-Paclitaxel Combined with Carboplatin and Tislelizumab as First-Line Treatment for Squamous Non-Small Cell Lung Cancer

Conditions

Non-Small Cell Lung Cancer

Keywords

SYHX2011; Enlonstobart; Squamous Non-small Cell Lung Cancer; First-Line Therapy

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (ORR) for phase II

  Objective response rate (ORR) is assessed by the investigator analysis of tumor growth through imaging follow-up (CT scan/MRI), using a method to evaluate it as RECIST V1.1. This will be considered as the number of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the period of treatment with SYHX2011. Tumor measurements that were assessed locally by the clinician according to RECIST, V1.1, should be recorded and indicate the change in size of tumors as compared with baseline, at the first dose of study treatment.

  Throughout the study period, an average of 3 years

• Progression Free Survival (PFS) for phase III

  Progression free survival (PFS): Time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment.

  Throughout the study period, an average of 3 years

Secondary Outcomes (6)

• Dose-Limiting Toxicity(DLT) only assessed in the safety run-in cohort

  From the first dose finished to 21 days

• Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  From the first dose finished to 28 days after the last dose

• ORR(iRECIST)

  Throughout the study period, an average of 3 years

• Disease Control Rate(DCR)

  Throughout the study period, an average of 3 years

• Duration of Response (DoR)

  Throughout the study period, an average of 3 years

Study Arms (2)

SYHX2011+Carboplatin+Enlonstobart

EXPERIMENTAL

SYHX2011+Carboplatin+Enlonstobart, One cycle every 3 weeks for 4\~6 cycles. Maintenance therapy consists of SYHX2011 (administered every 6 weeks) and Enlonstobart (administered every 3 weeks), with a maximum duration of 2 years, or until disease progression, intolerable toxicity, or withdrawal of informed consent by the patient, whichever occurs first.

Drug: SYHX2011; Drug: Carboplatin; Drug: Enlonstobart

Nab-Paclitaxel +Carboplatin+Tislelizumab

ACTIVE COMPARATOR

Nab-Paclitaxel +Carboplatin+Tislelizumab,One cycle every 3 weeks for 4\~6 cycles. Maintenance therapy consists of Nab-Paclitaxel (administered every 6 weeks) and Tislelizumab (administered every 3 weeks), with a maximum duration of 2 years, or until disease progression, intolerable toxicity, or withdrawal of informed consent by the patient, whichever occurs first.

Drug: Nab-Paclitaxel; Drug: Carboplatin; Drug: Tislelizumab

Interventions

SYHX2011 DRUG

SYHX2011:260 mg/m\^2, IV/30 ± 3 minutes(day1)

Also known as: Paclitaxel for Injection(Albumin Bound)(II)

SYHX2011+Carboplatin+Enlonstobart

Carboplatin DRUG

Carboplatin: AUC 5 mg/mL/min, IV/30\~60 minutes(day1)

SYHX2011+Carboplatin+Enlonstobart

Enlonstobart DRUG

Enlonstobart: 360 mg, IV/60 minutes(day1)

Also known as: SG001

SYHX2011+Carboplatin+Enlonstobart

Nab-Paclitaxel DRUG

Nab-Paclitaxel: 260 mg/m\^2, IV/30 ± 3 minutes(day1)

Also known as: Albumin-bound Paclitaxel

Nab-Paclitaxel +Carboplatin+Tislelizumab

Tislelizumab DRUG

Tislelizumab: 200 mg, IV/60 minutes(day1)

Nab-Paclitaxel +Carboplatin+Tislelizumab

Eligibility Criteria

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

You may qualify if:

• Age: ≥18 years old
• Histologically or cytologically confirmed locally advanced or metastatic squamous non-small cell lung cancer (Stage IIIB, IIIC, or IV according to the IASLC 9th Edition TNM Staging System), ineligible for radical surgery and/or radical radiotherapy
• Confirmed negative for driver genes (including EGFR mutation, ALK fusion, ROS1 fusion, etc.)
• Tumor cell PD-L1 expression in tumor tissue ≥1% (TPS ≥1%)
• No prior systemic anti-tumor therapy for Stage IIIB/IIIC and IV NSCLC, including chemotherapy, targeted therapy, biological therapy, immunotherapy, immunomodulatory drugs, Chinese herbal medicines or proprietary Chinese medicines, and other investigational drugs for tumor control
• ECOG PS score 0\~1
• At least one measurable lesion according to the RECIST 1.1 criteria
• Adequate bone marrow and other organ functions:(1)Hematology: No significant signs of hematological disease; absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelet count (PLT) ≥75×10\^9/L, hemoglobin (Hb) ≥90 g/L at screening. For patients with hematological indicators at the critical value who fail to meet the above criteria, the investigator will determine eligibility based on the patient's physical condition. (2)Coagulation function: International Normalized Ratio (INR) ≤1.5 × upper limit of normal (ULN); activated partial thromboplastin time (APTT) ≤1.5 × ULN. (3)Hepatic and renal function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≤2.5 × ULN; for patients with hepatic metastasis, both AST and ALT ≤5 × ULN. Total bilirubin (TBiL) ≤1.5 × ULN; for patients with known Gilbert's disease: serum total bilirubin level ≤3 × ULN. Serum creatinine (Cr) ≤1.5 × ULN
• Expected survival ≥3 months
• Able to understand the study details; the patient and/or legal guardian voluntarily consents to participate in the study and signs the informed consent form

You may not qualify if:

• History of or current with other malignant tumors (excluding non-melanoma skin cancer, in situ breast cancer, in situ cervical cancer, and superficial bladder cancer that have been effectively controlled within the past 5 years)
• Active leptomeningeal disease or poorly controlled, untreated brain metastases (excluding patients with brain metastases that are well-controlled with local therapy)
• Interstitial lung disease (ILD), drug-induced interstitial pneumonitis, or non-infectious pneumonitis (including radiation pneumonitis, pulmonary fibrosis, acute lung disease requiring steroid therapy), and patients with severe impairment of pulmonary function
• Active autoimmune disease or a history of autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.). However, participants with the following conditions are eligible for further screening: well-controlled type 1 diabetes mellitus; well-controlled hypothyroidism requiring only hormone replacement therapy; dermatological diseases not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia); or participants with diseases not expected to relapse in the absence of external triggers
• Peripheral neuropathy of Grade ≥2 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0
• Pleural effusion, peritoneal effusion, or pericardial effusion requiring clinical intervention within 2 weeks prior to the first administration of the study drug
• History of severe cardiovascular disease within 6 months prior to the first administration of the study drug, including but not limited to:(1)Severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.); Fridericia-corrected QT interval (QTcF) \> 480 ms (Fridericia formula: QTcF=QT/RR\^0.33, where RR=60/heart rate);(2)History of myocardial infarction, unstable angina pectoris, angioplasty, or coronary artery bypass graft surgery;(3)Heart failure of New York Heart Association (NYHA) Functional Class Ⅱ or higher; left ventricular ejection fraction (LVEF) \< 50% as detected during screening
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: Hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (anti-HBc) positive, with HBV DNA copy number ≥ 1×10\^4 copies/mL (or ≥ 2000 IU/mL); Hepatitis C virus antibody (anti-HCV) positive, with HCV RNA level exceeding the lower limit of quantification (LLOQ) of the applied analytical method
• Severe infection occurring within 4 weeks prior to the first study drug administration (including but not limited to bacteremia requiring hospitalization, severe pneumonia, active pulmonary tuberculosis, etc.); active infection requiring systemic antibiotic therapy within 2 weeks prior to the first study drug administration
• Lactating or pregnant females; females of childbearing potential with a positive blood pregnancy test within 7 days before study enrollment; all male and female patients of childbearing potential who decline to use highly effective contraceptive methods throughout the study period and for 6 months after the last drug administration
• Known hypersensitivity or anaphylaxis to any study drug, or a history of other severe hypersensitivity reactions
• History of immunodeficiency (including positive human immunodeficiency virus (HIV) test results, other acquired or congenital immunodeficiency diseases); a history of allogeneic stem cell or organ transplantation; other conditions that the investigator deems unsuitable for study participation (e.g., psychiatric disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus, etc.)

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Carboplatin; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; tislelizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share