Study of NXP900 With Lorlatinib in ALK+ Lung Cancer

NCT07784959 · tracked via the Priya Life Science USA tracker

Sponsor

Nuvectis Pharma, Inc.

Phase

Phase 1

Started

2026-08-17

Last updated

2026-08-25

Condition(s) studied

ALK PositiveALK Positive Non-small Cell Lung CancerNSCLCALK+ Non-Small-Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

NXP900Lorlatinib

NXP900: NXP900 is an orally administered inhibitor of SRC family kinases (SFK)

Lorlatinib: Lorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC)

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

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
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.
Disease Control Rate (DCR) — Up to approximately 12 months
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).

Trial sites (1)

Facility	City	Region	Status
NEXT Virginia	Fairfax	Virginia	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07784959 on ClinicalTrials.gov ↗ ← All trials in the USA