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NCT07315113PHASE1Recruiting

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

Nuvectis Pharma, Inc.

Start Date

12/18/2025

Completion Date

6/1/2027

Summary

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)

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

NXP900

DRUG

Osimertinib

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Conditions

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

Locations

Maryland Oncology Hematology

Calverton, Maryland 20705

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Willamette Valley Cancer Institute and Research Center

Eugene, Oregon 97401

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

NEXT Houston

Houston, Texas 77054

United States

NEXT Virginia

Fairfax, Virginia 22031

United States