In-vivo fluorescence molecular bronchoscopy of durvalumab-680LT in patients with unresectable stage III NSCLC after chemoradiation - PulmoPrint

Condition studied

Unresectable stage III non-small cell lung cancer

Investigational medicinal product(s)

Every trial of Durvalumab across our registers →

Eligibility

Primary endpoint

In vivo fluorescent signal of malignant lesions (pulmonary nodule or involved lymph node metastasis) assessed semi-quantitatively (tumor-to-background ratio [TBR]/contrast-to-noise ratio) and quantitatively (continuous data by MDSFR/SFF spectroscopy [pulmonary lesion] and/or USNB/SFF spectroscopy [lymph nodes] measurement). The signal is considered sufficient when a TBR greater than 2 is achieved, assessed both by the fluorescence camera system and by the spectroscopy system.

Endpoint detail

In vivo and ex vivo fluorescence signal, PD-L1 IHC score (assessed according to standard pathology protocols)., In vivo and ex vivo fluorescence signal, 1-, 2-and 5-year (long-term exploratory endpoint) event-free survival (defined as the time from the date of start of durvalumab treatment (index) to the first occurrence of any of the event (i) Disease progression, ii) Death from any cause. Patients who have not experienced an event at the time of analysis are censored., In vivo tumor-to-background ratio (please also refer to primary endpoint)., Adverse events according to CTCAE v5.0