Study of NXP900 With Lorlatinib in ALK+ Lung Cancer

A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer

This is a multi-center, open label, Phase 1b study of NXP900 in combination with lorlatinib in subjects with advanced, ALK-positive non-small cell lung cancer (NSCLC)

Inclusion Criteria:

• 18 years old or older
• Unresectable, metastatic or locally advanced ALK-positive NSCLC.
• Must have received lorlatinib as first or second line TKI
• One prior line of systemic chemotherapy is permitted
• Must have tolerated the dose level of lorlatinib actively being explored in the study or a higher dose

Exclusion Criteria:

• Known single or compound ALK domain mutations that cause resistance to lorlatinib, or known actionable oncogenic driver alterations other than ALK with approved targeted therapies available, such as, MET or EGFR mutations or HER2 overexpression
• Any contraindications to treatment with lorlatinib according to the lorlatinib United States Prescribing Information (USPI)