A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.

Официальное название

A Phase III, Randomized, Double-blind, Multicenter Clinical Study to Evaluate the Efficacy and Safety of SCTB14 Versus Pembrolizumab as First-Line Therapy in Patients With Driver Gene-Negative, TPS ≥10% Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Обзор

This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.

Вмешательства

• Препарат SCTB14
  SCTB14 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle.
• Препарат Pembrolizumab
  Pembrolizumab is administered at a fixed dose of 200 mg by intravenous infusion on Day 1 of each 3-week cycle.

Первичные конечные точки

• Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review [Срок оценки: Up to approximately 1.5 years]

Вторичные конечные точки (12)

• overall survival [Срок оценки: Up to approximately 5 years]
• Progression-Free Survival (PFS) as Assessed by Investigator [Срок оценки: Up to approximately 1.5 years]
• Confirmed Objective Response Rate (ORR) Assessed by Blinded Independent Central Review [Срок оценки: Up to approximately 1.5 years]
• Disease Control Rate (DCR) Assessed by Blinded Independent Central Review [Срок оценки: Up to approximately 1.5 years]
• Duration of Response （DOR）Assessed by Blinded Independent Central Review [Срок оценки: Up to approximately 1.5 years]
• Time to Response (TTR) [Срок оценки: Up to approximately 1.5 years]
• Treatment-Emergent Adverse Event（TEAE） [Срок оценки: The first dose of study drug until 30 days (±7 days) after the last dose]
• Serious adverse events (SAEs) [Срок оценки: From the first dose of study druguntil 60 days after the last dose.]
• immune-related adverse events (irAEs) [Срок оценки: From the first dose of study druguntil 60 days after the last dose]
• PD-L1 expression [Срок оценки: Up to approximately 1.5 years.]
• Quality of Life Questionnaire [Срок оценки: Up to approximately 1.5 years.]
• Quality of Life Questionnaire [Срок оценки: Up to approximately 1.5 years]

Критерии участия

Критерии включения

• Voluntarily sign the written informed consent form prior to screening.
• Age ≥ 18 years, both male and female.
• ECOG Performance Status score of 0 to 1.
• An expected survival of ≥ 3 months.
• Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) that is not amenable to curative surgery or radical concurrent/sequential chemoradiotherapy.
• For subjects with non-squamous cell carcinoma, as well as non-smoking subjects with squamous cell carcinoma containing mixed adenocarcinoma components, confirmation of the absence of EGFR sensitizing mutations or ALK gene rearrangements from tumor tissue is required prior to enrollment.
• Subjects must provide a histology sample suitable for PD-L1 testing, with a Tumor Proportion Score (TPS) ≥ 10%.
• No prior systemic anti-tumor therapy for the studied disease.
• At least one measurable non-CNS lesion according to RECIST v1.1 criteria.
• Adequate function of major organs.

Критерии исключения

• Known actionable driver gene mutations such as ROS1 fusion, BRAF V600E mutation, NTRK fusion, MET exon 14 skipping mutation, and RET fusion mutation.
• Received non-specific immunomodulatory therapy or immunosuppressive drugs within 2 weeks before the first dose; received traditional Chinese medicine with antineoplastic indications within 1 week before the first dose.
• Prior thoracic radiotherapy; or local anti-tumor therapy within 2 weeks before first dosing.
• Prior treatment with antitumor immunotherapy, antiangiogenic therapy, or other small molecule tyrosine kinase inhibitor (TKI)-based antitumor drugs.
• subjects with metastasis or compression involving the brainstem, meninges, or spinal cord, or those with active CNS metastases or multiple brain metastases.
• Imaging demonstrates tumor invasion of major blood vessels, significant necrosis or cavitation within the primary tumor lesions, or the presence of lymphangitic carcinomatosis.
• Imaging demonstrates tumor invasion or compression of adjacent vital organs or carries a risk of developing an esophagotracheal fistula or esophagopleural fistula.
• History of hypertensive crisis or hypertensive encephalopathy, or the presence of uncontrolled hypertension despite medication, or poorly controlled diabetes despite pharmacotherapy.
• A history of arterial thrombosis, deep vein thrombosis, cerebral infarction, transient ischemic attack, or significant vascular disease within 6 months prior to enrollment.
• A history of myocardial infarction, unstable angina, cardiac insufficiency with New York Heart Association (NYHA) class ≥ III, or severe arrhythmia uncontrolled by medication within 6 months prior to enrollment.
• The presence of any active autoimmune disease or a history of autoimmune disease with an anticipated recurrence.
• A history of esophageal/gastric varices, severe ulcer, abdominal fistula, intra-abdominal abscess, gastrointestinal perforation and/or fistula, acute gastrointestinal bleeding, intestinal obstruction, or extensive intestinal resection within 6 months prior to the first dose.
• A history of bleeding tendency, high bleeding risk, or coagulation dysfunction,.
• The presence of other malignant tumors.
• Toxicities from prior neoadjuvant/adjuvant therapy, surgery, radiotherapy, or other previous antitumor treatments have not recovered to Grade 0-1.
• Receipt of a live or attenuated vaccine within 4 weeks prior to the first dose, or a plan to receive a live or attenuated vaccine during the study period; however, the use of inactivated vaccines is permitted.
• Presence of any of the following infectious conditions: a) severe infection within 4 weeks prior to the first dose; b) active infection within 2 weeks prior to enrollment; c) active tuberculosis; d) positive HIV antibody; e) active hepatitis B or C; f) known active syphilis.
• Major surgery planned or anticipated during the study period, or unhealed tissue present before enrollment..
• Presence of symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
• A history of non-infectious pneumonia requiring treatment or the presence of interstitial lung disease
• A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Known hypersensitivity to any component of the investigational drug or a documented history of severe hypersensitivity reactions to any other monoclonal antibody.
• Current participation in another clinical trial, with the exception of observational (non-interventional) studies or the follow-up phase of an interventional trial.
• Pregnancy or lactation in female subjects.
• A known history of alcohol or drug addiction, psychiatric disorders, or drug abuse in the subject.
• Tumor-induced conditions or symptoms associated with a high medical risk.
• Any other condition deemed by the investigator to be inappropriate for enrollment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Chest Hospital — Шанхай

Идентификаторы

NCT: NCT07362459 · SCTB14-A301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗