Survival Outcomes of Lung Cancer

Официальное название

Survival Outcomes for Lung Cancer

Обзор

This is a prospective study to analyze the survival outcomes of different groups about lung cancer patients.

Подробное описание

This study aims to analyze the survival outcomes of different groups about lung cancer patients. All the groups were assessed to the treatment decisions guided by molecular profiling and clinical judgment of principal investigators

Вмешательства

• Препарат Treatment
  Treatment decisions guided by molecular profiling and clinical judgment of principal investigators

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Time from first subject dose to study completion, or up to 5 years]

Вторичные конечные точки (2)

• Overall survival (OS) [Срок оценки: Time from first subject dose to study completion, or up to 5 years]
• Adverse events (AEs) [Срок оценки: Time from first subject dose to study completion, or up to 5 years]

Критерии участия

Критерии включения

• Understand the requirements and contents of the clinical trial .
• Age ≥ 18 years.
• Histopathology or cytology confirmed lung cancer
• ECOG <=2.
• Predicted survival ≥ 12 weeks.
• Adequate bone marrow hematopoiesis and organ function
• Presence of measurable lesions according to RECIST 1.1.

Критерии исключения

• Subjects who have received any of the following treatments must be excluded:

• Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
• Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
• Presence of spinal cord compression or meningeal metastasis.
• History of other malignant tumors within 2 years.
• Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
• History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
• The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
• Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
• Heart-related diseases or abnormalities
• Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
• Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb drugs due to previous bowel resection.
• Live vaccine was given 2 weeks before the first medication.
• Women who are breastfeeding or pregnant.
• Hypersensitivity to the test drug and the ingredients.
• Other conditions assessed by the investigator to be unsuitable for participation in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Hunan Cancer Hospital — Чанша

Идентификаторы

NCT: NCT03647098 · 20180176

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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