Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer

Purpose

This is a multi-center, open label, Phase 1b study of NXP900 in combination with osimertinib in subjects with advanced, progressing, EGFR-mutated non-small cell lung cancer (NSCLC)

Conditions

  • EGFR Mutation Positive Non-small Cell Lung Cancer
  • EGFR Mutated Non-small Cell Lung Cancer Patients

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Provide written informed consent. 2. 18 years old or older. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Unresectable, metastatic or locally advanced EGFR-mutated NSCLC. 5. Prior treatment with osimertinib as first or second line, as single agent or in combination with chemotherapy, in the metastatic or locally advanced setting.

Exclusion Criteria

  1. Subject's cancer has a known oncogenic driver alteration other than EGFR. 2. Known EGFR mutations that cause resistance to osimertinib 3. Known human epidermal growth factor receptor 2 (HER2) overexpression 4. Any contraindications to treatment with osimertinib

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 (Part 1) 		Escalating doses of NXP900 given with osimertinib
  • Drug: NXP900
    NXP900 is an orally administered inhibitor of SRC family kinases (SFK)
  • Drug: Osimertinib
    Osimertinib is an orally available, irreversible, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor

Recruiting Locations

Maryland Oncology Hematology
Calverton, Maryland 20705

Willamette Valley Cancer Institute and Research Center
Eugene, Oregon 97401

UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232

NEXT Houston
Houston, Texas 77054

NEXT Virginia
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Nuvectis Pharma, Inc.

Study Contact

Erin Belshaw
12016278129
ebelshaw@nuvectis.com