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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Exploration (Part 1) | Experimental | Escalating doses of NXP900 given with osimertinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NXP900 | Drug | NXP900 is an orally administered inhibitor of SRC family kinases (SFK) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with treatment related adverse events and/or clinical laboratory abnormalities | Up to 30 days post treatment | |
| Objective response rate (ORR) | Best response of complete response (CR) or partial response (PR) per RECIST 1.1 | Up to approximately 12 months |
| Duration of Response (DoR) | Confirmed CR or PR from the first documented response to the date of documented disease progression or death. | Up to approximately 12 months |
| Disease Control Rate (DCR) | The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR). | Up to approximately 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erin Belshaw | Contact | 12016278129 | ebelshaw@nuvectis.com | |
| Shay Shemesh | Contact | sshemesh@nuvectis.com |
| Name | Affiliation | Role |
|---|---|---|
| Zofia Piotrowska, MD, MHS | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Oncology Hematology | Recruiting | Calverton | Maryland | 20705 | United States | |
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| Osimertinib | Drug | Osimertinib is an orally available, irreversible, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor |
|
| Massachusetts General Hospital |
| Not yet recruiting |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Willamette Valley Cancer Institute and Research Center | Recruiting | Eugene | Oregon | 97401 | United States |
| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| NEXT Houston | Recruiting | Houston | Texas | 77054 | United States |
| NEXT Virginia | Recruiting | Fairfax | Virginia | 22031 | United States |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000596361 | osimertinib |
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