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Trial details

A Single-Arm, Open-Label, Phase 1b/2 Study of SLC-391, an AXL Inhibitor, in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

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Trial short name: SKYLITE

Official title: A Single-Arm, Open-Label, Phase 1b/2 Study of SLC-391, an AXL Inhibitor, in Combination with Pembrolizumab in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Principal Investigator: Dr. Ines Menjak

Cancer type: Lung
Cancer location: Lung
Disease stage: Early Cancer
Trial phase: Phase 1, Phase 2
Intervention: Drug: SLC-391 Biological: Pembrolizumab

Registration #: NCT05860296

Contact e-mail: cancerclinicaltrials@sunnybrook.ca

Trial description:
SLC-391 is a novel, potent and specific small molecule inhibitor of receptor tyrosine kinase AXL with desirable potency and pharmaceutical properties. The study is being done to evaluate the safety and pharmacokinetic (PK) profile of SLC-391 in combination with pembrolizumab in participants with non-small cell lung cancer (NSCLC). Each treatment cycle lasts 21 days. Participants will swallow SLC-391 pills two times every day. Participants will get pembrolizumab intravenously (IV) from the study site staff on the first day of every cycle. This study has 2 parts. The first part will determine the recommended dose of SLC-391 in combination with pembrolizumab. The second part wants to find out if the combination of SLC-391 and pembrolizumab can help stop NSCLC tumours from growing or spreading.