A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC

Официальное название

A Randomized, Open, Controlled, Multicenter Phase II Clinical Study of RC108 in Combination With Furmonertinib Versus Furmonertinib for the First-Line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC

Обзор

Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC

Подробное описание

Primary objective: Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC Secondary objective: Evaluate the pharmacokinetic and immunogenicity characteristics of RC108 in combination with Furmonertinib

Вмешательства

• Препарат RC108
  RC108 in Combination With Furmonertinib
• Препарат Furmonertinib Mesilate Tablets Monotherapy
  Furmonertinib

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: 24 months]

Вторичные конечные точки (7)

• Progression-free survival (PFS) [Срок оценки: 24 months]
• Disease Control Rate (DCR) [Срок оценки: 24 months]
• Duration of Response (DoR) [Срок оценки: 24 months]
• Overall survival (OS) [Срок оценки: 45 months]
• Number of participants with adverse events (AEs) [Срок оценки: 24 months]
• Incidence of RC108 anti-drug antibody (ADA) [Срок оценки: 24 months]
• Pharmacokinetic profile of RC108 [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Voluntarily participate in the study and signed the ICF;
• Male or female, aged 18-75 years;
• All participants to be enrolled must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced (stage IIIB/IIIC )or recurrent metastatic NSCLC (stage IV ) and not amendable to curative surgery or radiation as assessed by investigator;
• For previously locally advanced or recurrent metastatic disease not treated with systemic antitumor therapy;
• Carring 1 of 2 common EGFR mutations clearly associated with EGFR-TKI sensitivity (i.e., exon 19 deletion or L858R) and MET positivity;
• Ability to provide at least 6 sections of tumor tissue specimens for staining and testing；
• ECOG PS score 0 or 1；
• At least one measurable lesion according to RECIST v1.1 criteria；
• Expected survival ≥ 12 weeks;
• Adequate bone marrow and organ function；
• Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose, during which time the female subject is not breastfeeding and the male subject avoids sperm donation.

Критерии исключения

• Subjects with the presence of meningeal metastases, spinal cord compression, or active brain metastases；
• Received ADC or MET inhibitors；
• Suffering from refractory nausea and vomiting, chronic gastrointestinal disorders, inability to swallow pharmaceutical preparations, or previous major bowel resection that may prevent adequate absorption, distribution, metabolism, or excretion of oral medications;
• Subjects with uncontrolled tumor-related pain；
• Use of an investigational drug or major surgery within 4 weeks before the first dose;
• Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study;
• Subjects with uncontrolled or severe cardiovascular disease;
• Presence of clinically uncontrollable third interstitial effusion;
• Presence of severe lung disease, including but not limited to active tuberculosis, interstitial lung disease requiring treatment, radiation pneumonitis, etc.
• Toxicity due to prior antineoplastic therapy has not recovered to National Cancer Institute Commonly Used Criteria Terminology for Generic Adverse Events, Version 5.0, Grade 0-1;
• Persistent grade ≥2 sensory or motor neuropathy;
• Active infections requiring systemic IV antibiotic therapy within 7 days before the first dose, allowing routine antimicrobial prophylaxis;
• Positive test result for Human Immunodeficiency Virus (HIV) or history of Acquired Immune Deficiency Syndrome (AIDS);
• Active hepatitis B or HCV-positive subjects;
• Received systemic corticosteroid therapy with >10 mg/day prednisone or other immunosuppressive medications within 2 weeks before randomization;
• Other malignant tumor within 5 years before signed the informed consent form;
• Known hypersensitivity or delayed hypersensitivity to RC108, certain components of Furmonertinib or similar drugs or any contraindication to the drug;
• Poor compliance and unable to complete the study procedures as assessed by investigator;

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

Открытое

Основная цель

Лечение

Центры проведения

Китай · 34 центра

• Beijing Chest Hospital,Capital Medical Unniversity — Пекин
• The Fifth Medical Center of Chinese People's Liberation Army General Hospital — Пекин
• Binzhou Medical University Hospital — Binzhou
• Jilin Cancer Hospital — Changchun
• The Second Xiangya Hospital Of Central South University — Чанша
• Changzhou Cancer Hospital — Changzhou
• Sichuan Cancer Hospital — Чэнду
• West China hospitial of SiChuan University — Чэнду
• … и ещё 26 центров

Идентификаторы

NCT: NCT06962865 · RC108-C006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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