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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 18 (estimated) |
| Sponsor | Nuvectis Pharma, Inc. Industry-sponsored |
| Drugs / interventions | osimertinib, chemotherapy |
| Locations | 6 sites (Calverton, Maryland and 5 other locations) |
| Status | Recruiting |
| Started | December 18, 2025 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07315113 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
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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
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Osimertinib Plus SRS/SRT for EGFR-Mutant NSCLC with Symptomatic Brain Metastases
This study tests whether adding targeted brain radiotherapy to osimertinib helps control brain metastases in adults with EGFR-mutant NSCLC and neurological symptoms.
-
Osimertinib with Cyclosporine A for EGFR-mutant NSCLC
This phase II study tests whether adding cyclosporine A to osimertinib helps people with EGFR-mutant metastatic NSCLC who still have detectable tumor DNA in blood.
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Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic NSCLC
This trial tests whether surgically removing the main lung tumor, after initial osimertinib therapy, helps people with EGFR-mutant oligometastatic non-small cell lung cancer live longer without disease progression.
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Izalontamab Brengitecan with Osimertinib in EGFR-mutant NSCLC: first-line versus standard options
This study tests whether adding iza-bren to osimertinib can help people with newly diagnosed EGFR-mutant non-small cell lung cancer, compared with osimertinib alone or osimertinib plus platinum-based chemotherapy.
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BL-B01D1 with Osimertinib before/around surgery for EGFR-mutant resectable NSCLC
A Phase II/III trial tests if adding BL-B01D1 to osimertinib around surgery helps people with resectable EGFR-mutant non-small cell lung cancer.
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BL-B01D1 plus osimertinib vs osimertinib alone in unresectable EGFR-mutated NSCLC (Stage III) after chemoradiation
This trial tests whether adding BL-B01D1 to osimertinib helps people with unresectable Stage III EGFR-mutated non-small cell lung cancer who did not progress after platinum-based chemoradiation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.