JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs.

Официальное название

A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of JYP0322 Versus Platinum-Based Chemotherapy in ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Previously Treated With ROS1-TKI Therapy.

Обзор

The primary purpose of the study was to compare progression-free survival of JYP0322 vs. platinum-based doublet chemotherapy in patients previously treated with ROS1-TKIs. Patients in the chemotherapy arm are given the option to switch to JYP0322 after BICR confirmed progressive disease (PD), while also have the choice to pursue with other drugs after discussing with their physicians.

Подробное описание

This is a phase III, open label, randomized study assessing JYP0322 (150 mg, orally, tid) versus platinum-based doublet chemotherapy in subjects with confirmed diagnosis of ROS1 fusion positive NSCLC, who have progressed following prior therapy with one or two approved ROS1 Tyrosine Kinase Inhibitor (ROS1-TKI) agents and whose tumors harbors a ROS1 fusion positive. Subjects must agree to provide a biopsy for central confirmation of ROS1 fusion status. A total of 207 patients will be randomly assigned in a 2:1 ratio to receive oral JYP0322 (at a dose of 150mg tid) or intravenous pemetrexed (500 mg per square meter of body-surface area) plus carboplatin (target area under the curve 5 \[AUC5\]) every 3 weeks for up to six cycles. Patients without disease progression after four cycles of platinu

Вмешательства

• Препарат Pemetrexed injection
  Randomization to either JYP0322 or platinum-based doublet-chemotherapy on Day 1 of every 21d cycle in a 2:1 (JYP0322: platinum-based doublet-chemotherapy) ratio
• Препарат Cross-over to JYP0322
  Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by BICR, they will be given the opportunity to begin treatment with JYP0322 150mg tid. These subjects may continue treatment with JYP0322 if they are continuing to show clinical benefit until disease progression as judged by the investigator.
• Препарат JYP0322 tablets
  JYP0322, 150 mg, administered orally three times daily (tid) after meals; sample size (N) = 60.

Первичные конечные точки

• Progression Free Survival (PFS) by BICR Assessment [Срок оценки: UP to 3 years]

Вторичные конечные точки (6)

• Progression Free Survival (PFS) by investigators Assessment [Срок оценки: UP to 3 years]
• Overall Survival (OS) [Срок оценки: UP to 5 years]
• Objective Response Rate (ORR) by Investigator and BICR assessment [Срок оценки: RECIST tumor assessments every 6 weeks from randomization up to 3 years.]
• Duration of Response (DOR) by Investigator and BICR assessment [Срок оценки: RECIST tumor assessments every 6 weeks from randomization up to 3 years.]
• Disease Control Rate (DCR) by Investigator and BICR assessment [Срок оценки: RECIST tumor assessments every 6 weeks from randomization up to 3 years.]
• Time to Response (TTR) by Investigator and BICR assessment [Срок оценки: RECIST tumor assessments every 6 weeks from randomization up to 3 years.]

Критерии участия

Критерии включения

• Key Inclusion Criteria

• Subjects with histologically or cytologically documented NSCLC.
• Locally advanced or metastatic ROS1 fusion positive NSCLC.
• Prior one or two ROS1-TKI(s) Treatment.
• World Health Organization (WHO) performance status 0-1.
• Life expectancy of at least 3 months.
• At least one measurable lesion according to RECISIT 1.1.

Критерии исключения

• Key Exclusion Criteria:

• Current participation in another therapeutic clinical trial.
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.
• A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.
• All acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade more than 1.
• 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.
• Known active infe

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07154368 · JYP0322M302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗