Neoadjuvant Almonertinib Followed by Adebrelimab-based Chemo-immunotherapy in II-IIIB EGFR-mutant Non-small Cell Lung Cancer, a Single Arm, Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Major Pathological Response (MPR)
研究概览
简要总结
Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions.
详细描述
This study plans to include 32 eligible II-IIIB non small cell lung cancer (NSCLC), patients will receive 6 weeks of almonertinib, and to avoid overlap of interstitial lung disease (ILD) and immune-related pneumonitis, 2 weeks of washout period was designed before 3 cycles of adebrelimab + doublet platinum-based chemotherapy is administered. Dynamic blood samples before, during or after neoadjuvant treatment will be obtained for exploratory analysis. Patients with local disease and resectable or potentially resectable NSCLC will receive anatomic resection. Patients who progress upon neoadjuvant treatment and further assessed as unresectable disease will be scheduled for local radiation or other potential subsequent treatment regarding multidisciplinary discussion. After completion of local treatment (surgery or radiation), patients will undergo optional adjuvant treatment including epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) or immunotherapy upon investigators' consideration or CT surveillance. Patients will be follow-up within 5 years after surgery. The primary endpoint of this study is major pathological response (MPR) defined as no more than 10% residual tumor found in primary lung cancer as per International Association for the Study of Lung Cancer (IASLC) criteria.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female,Age: 18 Years and older,
- •Subjects voluntarily joined the study and signed informed consent,
- •pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition),
- •ECOG PS=0 or 1,
- •resectable or potentially resectable, or resectability discussed by MDT,
- •harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q
- •measurable lesion as per RECIST1.1.
排除标准
- •pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer,
- •non small cell lung cancer harboring other driver gene alteration with approved targeted drugs,
- •with malignant plural effusion,
- •previous treatment to non small cell lung cancer other than this regimen,
- •received thoracic radiotherapy,
- •currently enrolled in other clinical trial,
- •active or known or suspected autoimmune disease.
研究组 & 干预措施
Almonertinib and Chemo-immunotherapy
6 weeks of almonertinib followed by 3 cycles of neoadjuvant adebrelimab (1200mg every 3 weeks) with nab-paclitaxel and carboplatin (nab-paclitaxel 135 mg/m2, d1 and d8, and carboplatin AUC 5, d1 every 3 weeks) will be administered before surgery, followed by optional adjuvant treatment including EGFR-TKIs up to 3 years or immunotherapy for up to 1 year or till disease progression or unacceptable toxicity.
干预措施: almonertinib (Drug)
Almonertinib and Chemo-immunotherapy
6 weeks of almonertinib followed by 3 cycles of neoadjuvant adebrelimab (1200mg every 3 weeks) with nab-paclitaxel and carboplatin (nab-paclitaxel 135 mg/m2, d1 and d8, and carboplatin AUC 5, d1 every 3 weeks) will be administered before surgery, followed by optional adjuvant treatment including EGFR-TKIs up to 3 years or immunotherapy for up to 1 year or till disease progression or unacceptable toxicity.
干预措施: Carboplatin (Drug)
Almonertinib and Chemo-immunotherapy
6 weeks of almonertinib followed by 3 cycles of neoadjuvant adebrelimab (1200mg every 3 weeks) with nab-paclitaxel and carboplatin (nab-paclitaxel 135 mg/m2, d1 and d8, and carboplatin AUC 5, d1 every 3 weeks) will be administered before surgery, followed by optional adjuvant treatment including EGFR-TKIs up to 3 years or immunotherapy for up to 1 year or till disease progression or unacceptable toxicity.
干预措施: Nab paclitaxel (Drug)
结局指标
主要结局
Major Pathological Response (MPR)
时间窗: MPR will be assessed within 2 weeks after surgery
MPR was defined as percentage of tumor cells within tumor bed less than 10% for primary lung lesions
次要结局
- Pathological Complete Response (pCR)(pCR will be assessed within 2 weeks after surgery)
- Objective Response Rate (ORR)(Tumor response will be evaluated within 2 weeks after almonertinib, and within 3-4 weeks after last dose of neoadjuvant treatment)
研究者
Wen-zhao ZHONG
Principal Investigator
Guangdong Provincial People's Hospital
