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

December 18, 2025 updated by: Nuvectis Pharma, Inc.

A Phase 1b Clinical Study of NXP900 in Combination With Osimertinib in Subjects With Advanced, EGFRMut+ 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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • Next Houston
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
Time Frame: Up to 30 days post treatment
Up to 30 days post treatment
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
Up to approximately 12 months
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.
Up to approximately 12 months
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).
Up to approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuvectis Pharma, Inc.

Investigators

  • Principal Investigator: Zofia Piotrowska, MD, MHS, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXP900-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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