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NCT 02194738 (ALCHEMIST)
ALCHEMIST研究：肺癌术后辅助治疗的优势人群标志物的识别和测序
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial. Primary outcome measures are central genotyping and feasibility of research grade tissue collection. Estimated enrollment is 8300 patients.
ALCHEMIST (NCT02193282) (未完成)
ALCHEMIST治疗试验：EGFR突变非小细胞肺癌完全切除术后厄洛替尼治疗
NCT 02193282 (An ALCHEMIST Treatment Trial) Randomized Study of Erlotinib vs Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC). Primary outcome measure is overall survival. Estimated enrollment is 450 patients.
III期研究，IB (T ≥ 4cm) – IIIA期，方案：CT vs CT + erlotinib for 2 y，样本量450，终点：OS
NCT 02193282 (An ALCHEMIST Treatment Trial) Randomized Study of Erlotinib vs Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC). Primary outcome measure is overall survival. Estimated enrollment is 450 patients.
NCT 02201992 (An ALCHEMIST Treatment Trial)
A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein. Primary outcome measure is overall survival. Estimated enrollment is 378 patients.
ALCHEMIST (02201992)
III期
入组人群：IB (T ≥ 4 cm) – IIIA
治疗：CT vs CT + crizotinib for 2 y
终点：OS
EA5142 (ANVIL; NCT02595944)
ALCHEMIST的一部分，III期试验，随机入组714例，辅助nivolumab对比标准治疗。病理证实的IB–IIIA NSCLC。
非小细胞肺癌术后和辅助化疗后纳武利尤单抗巩固治疗。
NCT 02595944 Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) - A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-Small Cell Lung Cancers. Primary outcome measures are overall survival and disease-free survival. Estimated enrollment is 714 patients.
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