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
This is a multicenter, open-Label, phase II/III study in patients with squamous non-small cell lung cancer. Phase II will adopt a single-arm study design. The first 12 enrolled patients will be designated as the safety run-in cohort. Upon completion of safety observation after the first dose administration, the recommended dose will be selected for the expansion phase based on the safety and efficacy outcomes of the safety run-in phase.If the Phase II study results demonstrate that the combination therapy at the recommended dose is tolerable and has a favorable safety profile in trial participants, with preliminary evidence of anti-tumor activity, the investigators will determine whether to initiate the Phase III study. The current guideline-recommended first-line treatment regimen is planned to be selected as the control arm, and a randomized, controlled, open-label study design will be adopted. Participants will receive the study regimen (experimental arm) or the control regimen in accordance with the randomization results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
396
SYHX2011:260 mg/m\^2, IV/30 ± 3 minutes(day1)
Carboplatin: AUC 5 mg/mL/min, IV/30\~60 minutes(day1)
Enlonstobart: 360 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.
Time frame: 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.
Time frame: Throughout the study period, an average of 3 years
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.
Time frame: From the first dose finished to 21 days
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.
Time frame: From the first dose finished to 28 days after the last dose
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Nab-Paclitaxel: 260 mg/m\^2, IV/30 ± 3 minutes(day1)
Carboplatin: AUC 5 mg/mL/min, IV/30\~60 minutes(day1)
Tislelizumab: 200 mg, IV/60 minutes(day1)
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.
Time frame: Throughout the study period, an average of 3 years
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.
Time frame: Throughout the study period, an average of 3 years
Duration of Response (DoR)
Duration of response (DoR): is defined as the time from first confirmed response (complete (CR) or partial (PR) response), to the date of the documented progression of the disease (PD) as determined using RECIST V1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.
Time frame: Throughout the study period, an average of 3 years
Overall Survival
Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the end of the study or was lost to follow-up, survival time was censored at their last contact date or the end of the study date, whichever was first.
Time frame: Throughout the study period, an average of 5 years