ALK+ Non-Small-Cell Lung Carcinoma, ALK Positive, ALK Positive Non-small Cell Lung Cancer, NSCLC
Conditions
Brief 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)
Interventions
DRUGNXP900
NXP900 is an orally administered inhibitor of SRC family kinases (SFK)
DRUGLorlatinib
Lorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC)
Sponsors
Nuvectis Pharma, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | Up to approximately 12 months | The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR). |
| Duration of Response (DoR) | Up to approximately 12 months | Confirmed CR or PR from the first documented response to the date of documented disease progression or death. |
| Number of patients with treatment related adverse events and/or clinical laboratory abnormalities | Up to 30 days post treatment | — |
| Objective response rate (ORR) | Up to approximately 12 months | Best response of complete response (CR) or partial response (PR) per RECIST 1.1 |
Countries
United States
Contacts
CONTACTErin Belshaw
CONTACTShay Shemesh
PRINCIPAL_INVESTIGATORChristine Lovly, MD, PhD
City of Hope Medical Center
Outcome results
None listed