Unresectable stage III non-small cell lung cancer
Conditions
Brief summary
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.
Detailed description
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
Interventions
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed