A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer

Официальное название

A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation

Обзор

This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.

Подробное описание

WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ (TKI sensitivity conferring mutation) and dual EGFRm+/C797S+ (third-generation TKI as first-line resistance conferring mutation) receptor forms of EGFR with selectivity margin over wild-type EGFR. Therefore WSD0922-FU has the potential to provide clinical benefit to patients with advanced NSCLC harboring both the single sensitivity mutations and the resistance mutation following first-line therapy with a third-generation EGFR TKI (e.g., Osimertinib). The clinical development program with WSD0922-FU will assess the safety and efficacy of WSD0922-FU in patients with advanced NSCLC whose cancers have progressed with or without brain metastasis following a first-line Osimertinib treatment.

Вмешательства

• Препарат WSD0922-FU Tablets, Dose level A
  Oral, 21 days in each cycle
• Препарат WSD0922-FU Tablets, Dose level B
  Oral, 21 days in each cycle

Первичные конечные точки

• ORR [Срок оценки: every 8 weeks, up to 1 year]

Вторичные конечные точки (7)

• Duration of Response (DoR) [Срок оценки: every 8 weeks, up to 1 year]
• PFS [Срок оценки: every 8 weeks, up to 1 year]
• Disease Control Rate (DCR) [Срок оценки: every 8 weeks, up to 1 year]
• Overall Survival (OS) [Срок оценки: 24 months]
• EORTC QLQ-C30 (HRQoL) [Срок оценки: up to 24 months]
• EORTC QLQ-LC13 (HRQoL) [Срок оценки: up to 24 months]
• PRO CTCAE (HRQoL) [Срок оценки: up to 24 months]

Критерии участия

Критерии включения

• Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.
• Male or female aged ≥18 years old.
• Histological or cytological confirmation diagnosis of NSCLC.
• Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.
• Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.
• Documented EGFR mutation .
• Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.
• At least one lesion, not previously irradiated and not chosen for biopsy during the study.
• Females should have evidence of non-childbearing potential.

Критерии исключения

• Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.
• Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.
• Symptomatic brain complications that require urgent neurosurgical or medical intervention.
• Any evidence of severe or uncontrolled systemic diseases.
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
• Past medical history of ILD.
• Inadequate bone marrow reserve or organ function as demonstrated.
• Males and females of reproductive potential.
• Known intracranial hemorrhage which is unrelated to tumor.
• Seizures requiring a change in anti-epileptic medications.

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

США · 8 центров

• FOMAT Oncology — Oxnard
• Cleveland Clinic Weston Hospital — Weston
• Karmanos Cancer Institute — Detroit
• Hackensack Meridian Health-Southern Ocean Medical Center — Manahawkin
• Cleveland Clinic — Cleveland
• UPMC Hillman Cancer Center — Pittsburgh
• TxO Central/South, Texas Oncology -Central/South Texas — Austin
• Virginia Cancer Specialists — Fairfax

Китай · 5 центров

• Fujian Provincial Cancer Hospital — Фучжоу
• Wuhan Union Hospital — Ухань
• Shanghai East hospital — Шанхай
• Shanghai Pulmonary Hospital — Шанхай
• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Франция · 5 центров

• Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou — Rennes
• Centre Hospitalier Universitaire CHU De Limoges — Limoges
• CHU Bordeaux - Centre Francois Magendie — Pessac
• Centre Francois Baclesse — Caen
• CHU Toulon - Hopital Sainte Musse — Toulon

Идентификаторы

NCT: NCT06868485 · WS2202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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