A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

Официальное название

A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC (Uncommon EGFR Mutations Only)

Обзор

The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).

Подробное описание

Sutetinib is an investigational irreversible EGFR tyrosine kinase inhibitor. EGFR is a gene that makes a protein that is involved in cell growth and cell survival. Mutated (changed) forms of the EGFR gene and protein have been found in some types of cancer, including non-small cell lung cancer. These changes may cause cancer cells to grow and spread in the body. The purpose of this study is to explore how effective sutetinib maleate capsules are for the treatment of patients with locally advanced or metastatic NSCLC with uncommon EGFR mutations.

Вмешательства

• Препарат Sutetinib Maleate Capsule
  Oral administration

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Pre-dose up to approximately 32 months post-dose]

Вторичные конечные точки (12)

• Duration of Response (DoR) [Срок оценки: Pre-dose up to approximately 32 months post-dose]
• Disease Control Rate (DCR) [Срок оценки: Pre-dose up to approximately 32 months post-dose]
• Progression Free Survival (PFS) [Срок оценки: Pre-dose up to approximately 32 months post-dose]
• Time to Tumor Progression (TTP) [Срок оценки: Pre-dose up to approximately 32 months post-dose]
• Time to Response (TTR) [Срок оценки: Pre-dose up to approximately 32 months post-dose]
• Time to Treatment Failure (TTF) [Срок оценки: Pre-dose up to approximately 32 months post-dose]
• Overall Survival (OS) [Срок оценки: Pre-dose up to approximately 32 months post-dose]
• 1-year Progression Free Survival [Срок оценки: Pre-dose up to 1 year post-dose]
• 1-year Survival [Срок оценки: Pre-dose up to 1 year post-dose]
• Area Under The Curve (AUC) of Sutetinib Maleate Capsule [Срок оценки: Pre-dose up to 24 hours post-dose]
• Maximum Plasma Concentration (Cmax) of Sutetinib Maleate Capsule [Срок оценки: Pre-dose up to 24 hours post-dose]
• Minimum Plasma Concentration (Cmin) of Sutetinib Maleate Capsule [Срок оценки: Pre-dose up to 24 hours post-dose]

Критерии участия

Критерии включения

• Age 18 years old and above, male or female
• Histopathological and/or cytopathological confirmation of locally advanced or metastatic NSCLC
• Confirmation that the tumor harbors an uncommon epidermal growth factor receptor (EGFR) mutation (tumor tissue biopsy)
• At least one measurable lesion
• Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
• A minimum life expectancy of > 3 months
• Adequate bone marrow reserve, hepatic, renal, and coagulation function

Other inclusion criteria apply for participating in the study.

Критерии исключения

• Participant ever used the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR TKI) for anti-tumor therapy prior to enrollment (Cohort 1), or second generation EGFR TKI (Cohort 2)
• Any systemic anti-tumor therapy such as chemotherapy and radiation therapy (including curative radiotherapy or spinal radiotherapy portion >30%) used within 3 weeks prior to enrollment; immunotherapy within 4 weeks; any palliative radiotherapy for non-target lesions used to relieve symptoms and traditional Chinese medicines indicated for the tumor within 2 weeks prior to enrollment; Cohort 2: any EGFR TKIs within 5 half-lives.
• Use or intake of drugs or foods containing potent inhibitors or inducers of cytochrome P450 isozyme 3A4 (CYP3A4) within 14 days or 5 half-lives, whichever is the longer, prior to enrollment
• Surgical operation (excluding aspiration biopsy) of main organs or a significant injury within 4 weeks prior to enrollment
• Any unresolved toxicities from prior therapy greater than National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAEv5.0) Grade 1, at the time of screening except for alopecia
• Inability to swallow the study medication, any seriously (NCI-CTCAEv5.0 ≥ Grade 3) chronic gastrointestinal disorder, malabsorption syndrome or any other conditions with influence on gastrointestinal absorption
• Active central nervous system metastases
• Any active infection which has not been controlled at screening

Other exclusion criteria apply for participating in the Study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• Oncology Physicians Network Healthcare — Glendale
• University of California San Diego Moores Cancer Center — La Jolla
• Moffitt Cancer Center — Tampa
• University Cancer & Blood Center (UCBC) - Athens — Athens
• Mission Cancer + Blood - Mission Cancer Foundation — Des Moines
• Norton Cancer Institute - Downtown — Louisville
• Northwell Health — New Hyde Park
• Perlmutter Cancer Center - 34th Street — New York
• … и ещё 1 центр

Идентификаторы

NCT: NCT06010329 · TL-EGFR-2201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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