本研究的主要目的是评估ramucirumab联合erlotinib对比安慰剂联合erlotinib在既往未经治疗、带有活化表皮生长因子受体（EGFR）突变（外显子19缺失及外显子21 L858R）的IV期非小细胞肺癌（NSCLC）受试者中的疗效与安全性。
适应症：Metastatic Non-Small Cell Lung Cancer
入组条件
纳入标准
- Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009).
- Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation \[exon 19 deletion or exon 21 (L858R) substitution mutation\].
- Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable (optional for part C).
- At least one measurable lesion.
- Life expectancy of at least 3 months.
排除标准
- Known T790M EGFR mutation (not applicable for Part C Period 2).
- Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
- Serious illness or medical condition.
- Ongoing treatment with CYP3A4 inducers or strong inhibitors.
- Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
- History of gross hemoptysis.
- Significant bleeding disorders.
- Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
- Radiographic evidence of intratumor cavitation.
- History of gastrointestinal perforation within last 6 months.
- History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
- History of any arterial thrombotic event within 6 months prior to enrollment.
- The participant has any known significant ophthalmologic abnormalities of the surface of the eye.
入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。