Phase II Clinical Study of SHR2554 Tablets Combined With Other Anti-tumor Treatments in Non-small Cell Lung Cancer Subjects

Официальное название

A Multicenter, Open Label Phase II Clinical Study on the Safety, Tolerability, and Efficacy of SHR2554 Tablets in Combination With Other Anti-tumor Treatments in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Обзор

Evaluate the safety, tolerability, and objective response rate (ORR) of SHR2554 tablets in combination with other anti-tumor treatments in subjects with locally advanced or metastatic non-small cell lung cancer

Вмешательства

• Препарат SHR2554; SHR-A2102
  SHR2554 tablets combined with SHR-A2102 for injection, with a cycle of 21 days
• Препарат SHR2554; Adabelimumab
  SHR2554 tablets combined with Adabelimumab, with a cycle of 21 days
• Препарат SHR2554; SHR-1701
  SHR2554 tablets combined with SHR-1701 injection, with a cycle of 21 days

Первичные конечные точки

• DLT [Срок оценки: 21days after the first administration of each subject]
• AE [Срок оценки: from Day1 to 30 days after last dose]
• Incidence and severity of serious adverse events (SAE) [Срок оценки: from Day1 to 30 days after last dose]
• ORR [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]

Вторичные конечные точки (5)

• Immunogenic indicators: anti-SHR-A2102 antibody (ADA) [Срок оценки: through study completion, an average of 2 years]
• Duration of response (DoR) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• disease control rate (DCR) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• progression free survival (PFS) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]
• overall survival (OS) [Срок оценки: from first dose to disease progression or death, whichever comes first, up to 3 years]

Критерии участия

Критерии включения

• Age range of 18-75 years old (including both ends), gender not limited;
• Patients with locally advanced unresectable or metastatic non-small cell lung cancer diagnosed by pathology
• ECOG score is 0 or 1
• Expected survival period ≥ 12 weeks
• Has a good level of organ function
• Patients voluntarily joined the study and signed informed consent

Критерии исключения

• Having difficulty swallowing or malabsorption syndrome or any other uncontrolled gastrointestinal disease (such as nausea, diarrhea, or vomiting), having undergone gastrectomy or gastric banding surgery, etc
• Symptomatic or active central nervous system tumor metastasis
• Previously or simultaneously suffering from other malignant tumors
• Spinal cord compression that cannot be cured by surgery and/or radiotherapy
• Accompanied by uncontrolled tumor related pain
• Plan to receive any other anti-tumor treatment during this trial period
• Receive other anti-tumor treatments within 4 weeks before the first medication
• Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration
• Currently participating in other clinical studies or taking medication for the first time less than 4 weeks after the end of the previous clinical study
• Moderate to severe pleural effusion with clinical symptoms
• Individuals with active pulmonary tuberculosis infection within one year prior to the first use of medication
• Subjects who have experienced severe infections within 30 days prior to their first medication use
• Administer attenuated live vaccine within 30 days before the first use of medication.
• History of immunodeficiency
• Suffering from poorly controlled or severe cardiovascular and cerebrovascular diseases
• History of interstitial pneumonia/non infectious pneumonia requiring hormone therapy in the past
• AE caused by previous anti-tumor treatment has not recovered to CTCAE v5.0 level evaluation ≤ 1
• Untreated active hepatitis
• Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study period.
• There are other serious physical or mental illnesses or laboratory abnormalities present

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07175220 · SHR2554-203-LC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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