Survival Outcomes for Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is a prospective study to analyze the survival outcomes of different groups about lung cancer patients.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the requirements and contents of the clinical trial .
- •Age ≥ 18 years.
- •Histopathology or cytology confirmed lung cancer
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •Presence of measurable lesions according to RECIST 1.1.
排除标准
- •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.
研究组 & 干预措施
Cohorts 1
Non-small cell lung cancer patients with EGFR mutations. Group A ： Single EGFR Drive gene Mutations Group B ：EGFR co-mutant with De novo MET alterations Group C ：EGFR co-mutant with other genes including ALK , ROS , RET , BRAF .etc
干预措施: Treatment (Drug)
Cohorts 2
Non-small cell lung cancer patients with ALK-fusion positive.
干预措施: Treatment (Drug)
Cohorts 3
Non-small cell lung cancer patients with ROS-1-positive.
干预措施: Treatment (Drug)
Cohorts 4
Non-small cell lung cancer patients with Other Rare Mutations.
干预措施: Treatment (Drug)
Cohorts 5
Driver-negative lung cancer patients with ADC and SQC.
干预措施: Treatment (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Time from first subject dose to study completion, or up to 5 years
PFS defines as first dose to first documented disease progression assessed by investigator or death due to any cause.
次要结局
- Overall survival (OS)(Time from first subject dose to study completion, or up to 5 years)
- Adverse events (AEs)(Time from first subject dose to study completion, or up to 5 years)
研究者
Yongchang Zhang
Professor, Director of Clinical Trial Center
Hunan Province Tumor Hospital