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Recruiting NCT07315113

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

Phase I Interventional EGFR Mutation Positive Non-small Cell Lung Cancer EGFR Mutated Non-small Cell Lung Cancer Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NXP900, Osimertinib.
Who it may be relevant to
Registry conditions: EGFR Mutation Positive Non-small Cell Lung Cancer, EGFR Mutated Non-small Cell Lung Cancer Patients. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

  • 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

Primary outcome measures

  • Number of patients with treatment related adverse events and/or clinical laboratory abnormalities [Time frame: Up to 30 days post treatment]
  • Objective response rate (ORR) [Time frame: Up to approximately 12 months]
  • Duration of Response (DoR) [Time frame: Up to approximately 12 months]
  • Disease Control Rate (DCR) [Time frame: Up to approximately 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Maryland Oncology Hematology — Calverton
  • Massachusetts General Hospital — Boston
  • Willamette Valley Cancer Institute and Research Center — Eugene
  • UPMC Hillman Cancer Center — Pittsburgh
  • NEXT Houston — Houston
  • NEXT Virginia — Fairfax

Identifiers

NCT: NCT07315113 · NXP900-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗