Clinical trial Recruiting at 5 sites Phase 1 Interventional Ages 18 and up

NXP900 plus osimertinib for advanced EGFR‑mutant non‑small cell lung cancer

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

Run by Nuvectis Pharma, Inc. · NCT07315113 · Data updated 2026-11-12

This trial will test whether adding NXP900 to osimertinib helps adults with advanced EGFR‑mutated non‑small cell lung cancer that has progressed on prior osimertinib.

More ALK-positive Non-small Cell Lung Cancer trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment18 (estimated)
SponsorNuvectis Pharma, Inc.
Industry-sponsored
Drugs / interventionsosimertinib, chemotherapy
Locations6 sites (Calverton, Maryland and 5 other locations)
StatusRecruiting
StartedDecember 18, 2025
Main results expectedDecember 2026
Study endsJune 2027
Registry record updatedJuly 9, 2026
Trial IDNCT07315113 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with unresectable or metastatic EGFR‑mutated NSCLC who progressed on prior osimertinib, have ECOG 0–1, and lack other known oncogenic driver alterations are the intended participants.

Probably not a fit

Patients whose tumors harbor other oncogenic drivers, known EGFR mutations that confer osimertinib resistance, HER2 overexpression, or who have contraindications to osimertinib are unlikely to benefit or are ineligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open‑label Phase 1b trial gives adults with unresectable or metastatic EGFR‑mutated NSCLC an experimental agent called NXP900 in combination with standard osimertinib. Eligible participants have disease that progressed on prior osimertinib and must have ECOG performance status 0–1 with no other known oncogenic driver alterations. The trial primarily focuses on safety, tolerability, and establishing dosing for the combination while also collecting preliminary evidence of anti‑tumor activity. Treatment and follow‑up visits are conducted at participating cancer centers with regular clinical assessments and imaging.

Why it matters

Potential benefit: If successful, the combination could help overcome resistance to osimertinib and slow tumor progression in patients who have progressed on prior osimertinib therapy.

How similar studies have gone: Combining new targeted agents with osimertinib has produced occasional promising responses in early‑phase studies, but results have been mixed and the specific agent NXP900 is a novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Maryland Oncology Hematology
    Calverton, Maryland, United States
    Recruiting
  • Willamette Valley Cancer Institute and Research Center
    Eugene, Oregon, United States
    Recruiting
  • UPMC Hillman Cancer Center
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • NEXT Houston
    Houston, Texas, United States
    Recruiting
  • NEXT Virginia
    Fairfax, Virginia, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Not yet recruiting

Study contacts

  • Principal investigator: Zofia Piotrowska, MD, MHS — Massachusetts General Hospital
  • Study coordinator: Erin Belshaw
  • Email: ebelshaw@nuvectis.com
  • Phone: 12016278129

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.