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Study of NXP900 With Lorlatinib in ALK+ Lung Cancer

RECRUITINGPhase 1Sponsored by Nuvectis Pharma, Inc.
Actively Recruiting
PhasePhase 1
SponsorNuvectis Pharma, Inc.
Started2026-08-17
Est. completion2027-08
Eligibility
Healthy vol.Accepted
Locations1 site

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

Healthy volunteers accepted
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)

Conditions6

ALK PositiveALK Positive Non-small Cell Lung CancerALK+ Non-Small-Cell Lung CarcinomaCancerLung CancerNSCLC

Interventions2

Locations1 site

NEXT Virginia
Fairfax, Virginia, 22031

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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