NL-OMON56597尚未招募不适用
A prospective, randomized study comparing chemotherapy versus chemotherapy plus immunotherapy in patients with advanced non-small cell lung cancer with low cTML and oncogenic driver,STK11 or KEAP1 mutation and a PD-L1 TPS<50%. - OMIT IO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 162
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >18 years 2. Advanced, metastatic non-small cell lung cancer UICC stage
- •IV 3. ECOG PS 0-2 4. PDL-1 TPS <50% (Dako 22C3) 5. Low cTML (<300 nonsynonymous
- •mutations) and either actionable mutation, inactivating STK11 or KEAP1
- •mutations as detected by NGS using OCA+ or TSO500 gene panel. 6. No prior
- •systemic therapy except for patients with activating mutations. 7. Fit for
- •treatment with chemo-immunotherapy deemed by the treating physician. 8.
- •Measurable disease (RECIST 1.1). 9. In case of activating mutation,
- •pretreatment with appropriate (i.e. guideline recommended) targeted therapy is
- •required with demonstrated disease progression.
排除标准
- •1. Symptomatic CNS metastasis requiring immediate radiotherapy or neurosurgical
- •intervention.
- •2. Any contra-indication (as per label) for treatment with immune checkpoint
- •inhibitors.
研究者
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