A Phase III Clinical Study of SI-B001 Combined With Docetaxel Second-line Therapy in Patients With Non-small Cell Lung Adenocarcinoma and Lung Squamous Cell Carcinoma Without Actionable Genomic Alterations Who Failed Only First-line Treatment With PD-1/PD-L1 Monoclonal Antibody Plus Platinum-Based Chemotherapy
Main objectives: To evaluate the benefit of SI-B001+ docetaxel on overall survival (OS) of bidotaxel. To evaluate the benefit of SI-B001+ Docetaxel over Docetaxel's progression-free survival (PFS) based assessment. Secondary objectives: To evaluate the investigator-evaluated progression-free survival (PFS) benefit of SI-B001+ Docetaxel against docetaxel; To evaluate the difference of objective response rate (ORR), disease control rate (DCR) and duration of response (DOR) between SI-B001+ docetaxel and bidocetaxel. To evaluate the type, frequency and severity of adverse events (TEAE) and drug-related adverse events (TRAE) during treatment with SI-B001+ docetaxel in comparison with docetaxel. The pharmacokinetic (PK) characteristics of SI-B001 will be evaluated. The immunogenicity of SI-B001 will be evaluated. Subject quality of life.
• Sign the informed consent form voluntarily and follow the protocol requirements;
• Gender is not limited;
• Age ≥18 years old and ≤80 years old;
• Expected survival time ≥3 months;
• Patients with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer;
• Subjects had to consent to complete ctDNA testing during the screening period;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
⁃ No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
⁃ No blood transfusion is allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements on the premise that albumin and colony-stimulating factor are not allowed;
⁃ Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
⁃ Proteinuria ≤2+ or \< 1000mg/24h;
⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.