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

NCT ID: NCT07315113

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-18

Study Completion Date

2027-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Exploration (Part 1)

Escalating doses of NXP900 given with osimertinib

Group Type EXPERIMENTAL

NXP900

Intervention Type DRUG

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

Osimertinib

Intervention Type DRUG

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

Interventions

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NXP900

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

Intervention Type DRUG

Osimertinib

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nuvectis Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zofia Piotrowska, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

NEXT Houston

Houston, Texas, United States

Site Status RECRUITING

NEXT Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Belshaw

Role: CONTACT

12016278129

Shay Shemesh

Role: CONTACT

Other Identifiers

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NXP900-103

Identifier Type: -

Identifier Source: org_study_id

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