Study of NXP900 With Lorlatinib in ALK+ Lung Cancer

Purpose

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

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Exploration 		Escalating doses of NXP900 given with lorlatinib
  • Drug: NXP900
    NXP900 is an orally administered inhibitor of SRC family kinases (SFK)
  • Drug: Lorlatinib
    Lorlatinib is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC)

Recruiting Locations

NEXT Virginia
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Nuvectis Pharma, Inc.

Study Contact

Erin Belshaw
2016278129
ebelshaw@nuvectis.com