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Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer
NCT07315113 · Nuvectis Pharma, Inc.
In plain English
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Official title
A Phase 1b Clinical Study of NXP900 in Combination With Osimertinib in Subjects With Advanced, EGFRMut+ Non-Small Cell Lung Cancer
About this study
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)
Eligibility 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
Study design
Enrollment target: 18 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-18
Estimated completion: 2027-06
Last updated: 2026-01-02
Interventions
Drug: NXP900Drug: Osimertinib
Primary outcomes
- • Number of patients with treatment related adverse events and/or clinical laboratory abnormalities (Up to 30 days post treatment)
- • Objective response rate (ORR) (Up to approximately 12 months)
- • Duration of Response (DoR) (Up to approximately 12 months)
Sponsor
Nuvectis Pharma, Inc. · industry
Contacts & investigators
ContactErin Belshaw · contact · ebelshaw@nuvectis.com · 12016278129
ContactShay Shemesh · contact · sshemesh@nuvectis.com
InvestigatorZofia Piotrowska, MD, MHS · principal_investigator, Massachusetts General Hospital
All locations (3)
Massachusetts General HospitalNot Yet Recruiting
Boston, Massachusetts, United States
NEXT HoustonRecruiting
Houston, Texas, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States