Trial Profile

An open-label, non-randomized, single dose, exploratory Phase II trial of FG001 (an imaging agent) for localization of biopsy-proven primary non-small cell lung cancer (NSCLC)

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 15 Sep 2023

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At a glance

12 Sep 2023 Planned number of patients changed from 24 to 44.
22 Jun 2023 Status changed from recruiting to completed.
24 Aug 2022 According to a FluoGuide media release, first interim analysis following evaluation of 8 patients is anticipated in Q4 2022 and top line data in H1 2023. The trial was approved in March 2022 and initiated in May 2022. Due to slower-than-anticipated patient enrollment, the company has amended the protocol with broader inclusion criteria, which has now been approved by both the Ethical Committee and the DMA in Denmark.

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