EGFR Mutated Non-small Cell Lung Cancer Patients, EGFR Mutation Positive Non-small Cell Lung Cancer
Conditions
Keywords
EGFR, Epidermal growth factor receptor, NSCLC, non-small cell lung cancer, lung cancer, osimertinib, NXP900, EGFR mutation
Brief 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)
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
Sponsors
Nuvectis Pharma, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Best response of complete response (CR) or partial response (PR) per RECIST 1.1 |
| Duration of Response (DoR) | Up to approximately 12 months | Confirmed CR or PR from the first documented response to the date of documented disease progression or death. |
| Disease Control Rate (DCR) | Up to approximately 12 months | The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR). |
Countries
United States
Contacts
CONTACTErin Belshaw
CONTACTShay Shemesh
PRINCIPAL_INVESTIGATORZofia Piotrowska, MD, MHS
Massachusetts General Hospital
Outcome results
None listed