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NCT Number: NCT07784959

Study of NXP900 With Lorlatinib in ALK+ Lung Cancer

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)

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Key information

Conditions

ALK Positive ALK Positive Non-small Cell Lung Cancer ALK+ Non-Small-Cell Lung Carcinoma NSCLC

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NEXT Virginia

Fairfax, Virginia, 22031, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

NXP900

Drug

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

Lorlatinib

Drug

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

Primary outcomes

  1. Number of patients with treatment related adverse events and/or clinical laboratory abnormalities

    Time frame: Up to 30 days post treatment

  2. Objective response rate (ORR)

    Time frame: Up to approximately 12 months

    Best response of complete response (CR) or partial response (PR) per RECIST 1.1

  3. Duration of Response (DoR)

    Time frame: Up to approximately 12 months

    Confirmed CR or PR from the first documented response to the date of documented disease progression or death.

  4. Disease Control Rate (DCR)

    Time frame: Up to approximately 12 months

    The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Belshaw

CONTACT

[email protected]

2016278129

Shay Shemesh

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nuvectis Pharma, Inc.

Industry

Registry information

Official study title

A Phase 1b Clinical Study of NXP900 in Combination With Lorlatinib in Subjects With Advanced, ALK-positive, Non-Small Cell Lung Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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