Study of NXP900 With Lorlatinib in ALK+ Lung Cancer
Purpose
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)
Conditions
- ALK Positive
- ALK Positive Non-small Cell Lung Cancer
- NSCLC
- ALK+ Non-Small-Cell Lung Carcinoma
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Dose Exploration |
Escalating doses of NXP900 given with lorlatinib |
|
Recruiting Locations
NEXT Virginia
Fairfax, Virginia 22031
Fairfax, Virginia 22031
More Details
- Status
- Recruiting
- Sponsor
- Nuvectis Pharma, Inc.