NXP900 with Lorlatinib in ALK-positive NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase 1b study evaluating the safety and feasibility of combining NXP900 with lorlatinib in adults with unresectable, metastatic, or locally advanced ALK-positive NSCLC. Eligible participants have previously received lorlatinib and may have had one prior chemotherapy regimen. Participants will receive NXP900 in combination with lorlatinib at a dose level under exploration to assess tolerability and preliminary activity. The study is conducted at a single site, NEXT Virginia, under the lead sponsorship of Nuvectis Pharma, with no listed collaborators. Results will inform future dosing and potential signals of efficacy for this combination.

Why it matters

Who can join: the full rules

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)

Where it's running

• NEXT Virginia
  Fairfax, Virginia, United States Recruiting

Study contacts

• Principal investigator: Christine Lovly, MD, PhD — City of Hope Medical Center
• Study coordinator: Erin Belshaw
• Email: ebelshaw@nuvectis.com
• Phone: 2016278129

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.