Osimertinib as Neoadjuvant Therapy in Patients With Resectable Stage II-IIIB EGFR-mutated Lung Squamous Cell Carcinoma: A Single-centre, Single-arm, Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Safety: frequency of severe adverse events
研究概览
简要总结
Previous trials, such as ADURA and CTONG, have demonstrated the benefits of neoadjuvant targeted therapy in patient with EGFR mutations , which can effectively reduce the extent of tumors and improve the survival outcomes. However, clinical trials of neoadjuvant targeted therapy in NSCLC have rarely enrolled patients with EGFR-mutated lung squamous cell carcinoma due to its rarity, which means that the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma remains controversial.
详细描述
This trial aims to investigated the safety and feasibility of neoadjuvant osimertinib in patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest CT and pathological examination confirmed as resectable II-IIIB lung squamous cell carcinoma;
- •Gene text confirmed EGFR mutation;
- •PET-CT confirmed no metastasis;
- •ECOG physical status score 0-1;
- •Age ≥ 18 years;
- •Have one measurable lesion at least;
- •Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be < 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN
- •Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after treatment, and the urine or serum pregnancy test results less than 7 days before entering the group were negative. Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after treatment;
- •Sign informed consent.
排除标准
- •Patients with other malignant tumors in the five years before the start of this trial.
- •Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure [higher than II (New York College of Cardiology)], severe arrhythmias, liver, kidney or metabolic diseases;
- •Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;
- •A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);
- •Allergic to experimental drugs;
- •Complicated with HIV infection or active hepatitis.
- •Vaccination within 4 weeks before the start of this trial;
- •Those who had undergone other major operations or severe injuries within the previous 2 months;
- •Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;
- •Pregnant or lactating women;
- •Those with neurological diseases or mental disorders;
- •Participated in another therapeutic clinical study at the same time;
- •Other researchers did not consider it appropriate to enroll in the group.
研究组 & 干预措施
Osimertinib
Patients with resectable stage II-IIIB EGFR-mutated lung squamous cell carcinoma will receive Osimertinib ( 80mg/d, ≥9 weeks).
干预措施: Osimertinib (Drug)
结局指标
主要结局
Safety: frequency of severe adverse events
时间窗: from the participants enrolling to 30 days after the last drug administration or 30 days after surgery.
The frequency of severe adverse events from the participants enrolling to 30 days after the last drug administration or 30 days after surgery.
Objective Response Rate, ORR
时间窗: analysis is completed 4 weeks after neoadjuvant treatment
Defined as the proportion of participants who had a complete response (CR) or partial response (PR) according to RECIST version 1.1 after treatment.
次要结局
- Major pathologic response, MPR(analysis is completed 4 weeks after surgery)
- Progression-free survival (PFS)(2 years)
- Disease control rate (DCR)(2 years)
- Duration of remission (DOR)(2 years)
- R0 rate(analysis is completed 4 weeks after surgery)
- Overall survival (OS)(5 years)
研究者
Shuben Li
Deputy Administrative Director of thoracic surgery
The First Affiliated Hospital of Guangzhou Medical University