NCT07784959PHASE1Recruiting
Study of NXP900 With Lorlatinib in ALK+ Lung Cancer
Nuvectis Pharma, Inc.
Start Date
8/17/2026
Completion Date
2/1/2028
Summary
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)
Eligibility Criteria
Age Range: No minimum to No maximum
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)
Interventions
DRUG
NXP900
DRUG
Lorlatinib
Conditions
ALK PositiveALK Positive Non-small Cell Lung CancerNSCLCALK+ Non-Small-Cell Lung Carcinoma
Locations
NEXT Virginia
Fairfax, Virginia 22031
United States