Recruiting
Phase 1

NXP900 & Lorlatinib

Sponsor:

Nuvectis Pharma, Inc.

Code:

NCT07784959

Conditions

ALK Positive

ALK Positive Non-small Cell Lung Cancer

NSCLC

ALK+ Non-Small-Cell Lung Carcinoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

NXP900

Lorlatinib

Study Details

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)

Conditions

ALK Positive

ALK Positive Non-small Cell Lung Cancer

NSCLC

ALK+ Non-Small-Cell Lung Carcinoma

Study ID

NCT07784959

Start date

Aug 17, 2026

Status verified date

Aug, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not 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)

Study Design

Enrollment

54 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Exploration

Escalating doses of NXP900 given with lorlatinib

Interventions

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)

Primary outcome measure

  • Number of patients with treatment related adverse events and/or clinical laboratory abnormalities [ Time Frame: Up to 30 days post treatment ]
  • Objective response rate (ORR) [ Time Frame: Up to approximately 12 months ]
  • Duration of Response (DoR) [ Time Frame: Up to approximately 12 months ]
  • Disease Control Rate (DCR) [ Time Frame: Up to approximately 12 months ]

Central Contacts and Locations

Central contacts

Erin Belshaw

2016278129ebelshaw@nuvectis.com

Shay Shemesh

sshemesh@nuvectis.com

Locations

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Nuvectis Pharma, Inc.

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nuvectis Pharma, Inc. on 2026-08-25.