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
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%)
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
Parallel
SYHX2011
DrugSYHX2011:260 mg/m\^2, IV/30 ± 3 minutes(day1)
Carboplatin
DrugCarboplatin: AUC 5 mg/mL/min, IV/30\~60 minutes(day1)
Enlonstobart
DrugEnlonstobart: 360 mg, IV/60 minutes(day1)
Nab-Paclitaxel
DrugNab-Paclitaxel: 260 mg/m\^2, IV/30 ± 3 minutes(day1)
Carboplatin
DrugCarboplatin: AUC 5 mg/mL/min, IV/30\~60 minutes(day1)
Tislelizumab
DrugTislelizumab: 200 mg, IV/60 minutes(day1)
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.
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.
Dose-Limiting Toxicity(DLT) only assessed in the safety run-in cohort
Adverse events (including signs, symptoms, diseases, and clinically significant abnormal laboratory test values) related to the study drug (with causal relationships categorized as definite, probable, or possible) occurring during the DLT observation period.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
To identify the incidence and the type of AEs, abnormalities in clinical laboratory assessments, ECGs, echocardiography, vital sign assessments, and physical exams.
ORR(iRECIST)
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 iRECIST.
Disease Control Rate(DCR)
The proportion of patients achieving complete response (CR), partial response (PR), and stable disease (SD) among all patients over the entire study period.
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