Studieoverzicht

Study name: ARROS-1

Histology	NSCLC
Tumor stage	Stage IV
Host / recruiting sites	Antoni van Leeuwenhoek, UMC Groningen
Enrollment	Recruiting
Therapy line	Later line (≥2L)
Design	A FIH, Phase 1/2, multicenter, open-label, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520
Intervention	NVL-520
Key inclusion criteria	Cohort 2a: Must be naïve to TKI therapy and up to one prior line of chemotherapy and/or immunotherapy. Cohort 2b: Must have received 1 prior ROS1 TKI therapy (either crizotinib or entrectinib) and no prior chemotherapy or immunotherapy. Cohort 2c: Must have received 1 prior ROS1 TKI therapy (either crizotinib or entrectinib) and 1 prior platinum-based chemotherapy with or without immunotherapy. Cohort 2d: Must have received at least 2 prior ROS1 TKI therapies (with crizotinib or entrectinib as initial ROS1 TKI) and up to 1 prior line of chemotherapy and/or immunotherapy. Cohort 2e: Must have progressed on any prior therapy (includes, but is not limited to, patients who have progressed on prior ROS1 TKIs).
Key exclusion criteria	Ongoing or recent anticancer therapy within the following timeframe prior to first dose of study drug (NVL-520 may be started within limits for prior TKI or chemotherapy if considered by the Investigator to be safe and within the best interest of the patient, with prior approval from the Sponsor): a. TKI or other anticancer therapy not listed below in exclusion criteria 4b or 4c Ongoing or recent radiation therapy within the following timeframe prior to first dose of study drug: a. Radiation therapy (except palliative radiation to relieve bone pain)
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