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RecruitingInterventionalPhase 1

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

NCT ID: NCT07315113Sponsor: Nuvectis Pharma, Inc.Last updated: 2026-01-02

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)

Arms & interventions

  • DrugNXP900

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

  • DrugOsimertinib

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

Outcome measures

Primary

  • 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)

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

    Time frame: Up to approximately 12 months

  • Duration of Response (DoR)

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

    Time frame: Up to approximately 12 months

  • Disease Control Rate (DCR)

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

    Time frame: Up to approximately 12 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114

Not Yet Recruiting

NEXT Houston

Houston, Texas, 77054

Recruiting

NEXT Virginia

Fairfax, Virginia, 22031

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