Study of NXP900 With Lorlatinib in ALK+ Lung Cancer

NCT07784959 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NXP900-102
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

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

  Up to 30 days post treatment

• Objective response rate (ORR)

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

  Up to approximately 12 months

• Duration of Response (DoR)

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

  Up to approximately 12 months

• Disease Control Rate (DCR)

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

  Up to approximately 12 months

Study Arms (1)

Dose Exploration

EXPERIMENTAL

Escalating doses of NXP900 given with lorlatinib

Drug: NXP900; Drug: Lorlatinib

Interventions

NXP900 DRUG

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

Dose Exploration

Lorlatinib DRUG

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

Dose Exploration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nuvectis Pharma, Inc.: lead

Study Sites (1)

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Interventions

lorlatinib

Study Officials

• Christine Lovly, MD, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Belshaw

CONTACT

2016278129; ebelshaw@nuvectis.com

Shay Shemesh

CONTACT

sshemesh@nuvectis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)