Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07315113

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

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)

Recruiting

Interested in participating?

Request Info

Key information

Conditions

EGFR Mutation Positive Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung EGFR Mutated Non-small Cell Lung Cancer Patients Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Maryland Oncology Hematology, Calverton, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide written informed consent.
  • 18 years old or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Unresectable, metastatic or locally advanced EGFR-mutated NSCLC.
  • 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

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

Treatment and study plan

NXP900

Drug

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

Osimertinib

Drug

Osimertinib is an orally available, irreversible, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor

Primary outcomes

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

    Time frame: Up to 30 days post treatment

  2. Objective response rate (ORR)

    Time frame: Up to approximately 12 months

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

  3. Duration of Response (DoR)

    Time frame: Up to approximately 12 months

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

  4. Disease Control Rate (DCR)

    Time frame: Up to approximately 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Belshaw

CONTACT

[email protected]

12016278129

Shay Shemesh

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nuvectis Pharma, Inc.

Industry

Registry information

Official study title

A Phase 1b Clinical Study of NXP900 in Combination With Osimertinib in Subjects With Advanced, EGFRMut+ Non-Small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 2, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.