2025-524816-13-00招募中2 期
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination with Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- MPR (≤10% residual cancer cells in the surgical specimen, per independent centralized pathology review)
研究概览
简要总结
To evaluate the antitumor effect of amivantamab in combination with lazertinib or carboplatin and pemetrexed in participants with resectable, EGFRmutated, Stage II-IIIB NSCLC in the neoadjuvant setting
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must have histologically or cytologically confirmed nonsquamous non-small cell lung cancer (NSCLC) with completely resectable Stage II-IIIB N2 disease
- •Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a multidisciplinary team evaluation
- •3.Participant must consent to a screening biopsy, if clinically feasible, if no adequate tumor tissue is available for a baseline sample
- •Participant may have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s). Prior or concurrent second malignancies must be reviewed and agreed to with the medical monitor
- •Have an eastern cooperative oncology group (ECOG) performance status of 0 or 1
排除标准
- •History of uncontrolled illness
- •Medical history of (non-infectious) interstitial lung disease (ILD)/ pneumonitis, or has current interstitial lung disease (ILD)/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
- •Suspected or known allergies, hypersensitivity, or intolerance to excipients of: the combination of amivantamab and lazertinib or carboplatin and pemetrexed
- •Presence of primary driver mutations (anaplastic lymphoma kinase [ALK], mesenchymal-epithelial transition [MET], human epidermal growth factor receptor 2 [HER2], proto-oncogene tyrosine-protein kinase ROS [ROS1], neurotrophic tyrosine receptor kinase [NTRK], B-Raf proto-oncogene [BRAF], REarranged during transfection [RET], or kirsten rat sarcoma viral oncogene homolog [KRAS]) , besides EGFR Exon 19del or Exon 21 L858R mutations, as determined by local genomic testing
- •Prior treatment with any systemic anti-cancer therapy for NSCLC including EGFR-tyrosine kinase inhibitor (TKI) therapy, chemotherapy, biologic therapy, immunotherapy, or any investigational drug
研究组 & 干预措施
JNJ-73841937
Test
干预措施: JNJ-73841937 (Drug)
JNJ-61186372
Test
干预措施: JNJ-61186372 (Drug)
结局指标
主要结局
MPR (≤10% residual cancer cells in the surgical specimen, per independent centralized pathology review)
MPR (≤10% residual cancer cells in the surgical specimen, per independent centralized pathology review)
次要结局
未报告次要终点
研究者
CTIS Point of Contact
Scientific
Janssen Cilag International
研究点 (3)
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