NXP900 plus osimertinib for advanced EGFR‑mutant non‑small cell lung cancer
A Phase 1b Clinical Study of NXP900 in Combination With Osimertinib in Subjects With Advanced, EGFRMut+ Non-Small Cell Lung Cancer
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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nuvectis Pharma, Inc. Industry-sponsored |
| Drugs / interventions | osimertinib, chemotherapy |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT07315113 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Boston, Massachusetts and 2 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- NEXT Houston — Houston, Texas, United States (Recruiting)
- NEXT Virginia — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Zofia Piotrowska, MD, MHS — Massachusetts General Hospital
- Study coordinator: Erin Belshaw
- Email: ebelshaw@nuvectis.com
- Phone: 12016278129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.