EGFR Mutation Positive Non-small Cell Lung CancerPhase 1NCT07315113
Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer
A Phase 1 study testing NXP900 and Osimertinib in people with EGFR Mutation Positive Non-small Cell Lung Cancer and EGFR Mutated Non-small Cell Lung Cancer Patients, run by Nuvectis Pharma, Inc. at 6 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EGFR Mutation Positive Non-small Cell Lung Cancer, EGFR Mutated Non-small Cell Lung Cancer Patients
- What is being tested?
- NXP900 and Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 6 sitesUnited States
- Study dates
- 18 Dec 2025to Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- 18 years old or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Unresectable, metastatic or locally advanced EGFR-mutated NSCLC.
- Prior treatment with osimertinib as first or second line, as single agent or in combination with chemotherapy, in the metastatic or locally advanced setting.
Who cannot join
- Subject's cancer has a known oncogenic driver alteration other than EGFR.
- Known EGFR mutations that cause resistance to osimertinib
- Known human epidermal growth factor receptor 2 (HER2) overexpression
- Any contraindications to treatment with osimertinib
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Shay Shemesh contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Maryland Oncology Hematology
Calverton, Maryland, 20705
- Recruiting
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon, 97401
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
NEXT Houston
Houston, Texas, 77054
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase 1b Clinical Study of NXP900 in Combination With Osimertinib in Subjects With Advanced, EGFRMut+ Non-Small Cell Lung Cancer
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)
- Conditions
- EGFR Mutation Positive Non-small Cell Lung Cancer, EGFR Mutated Non-small Cell Lung Cancer Patients
- Being tested
- NXP900, Osimertinib
- Keywords
- EGFR, Epidermal growth factor receptor, NSCLC, non-small cell lung cancer, lung cancer, osimertinib, NXP900, EGFR mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NXP900Drug
NXP900 is an orally administered inhibitor of SRC family kinases (SFK)
OsimertinibDrug
Osimertinib is an orally available, irreversible, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose Exploration (Part 1) | Experimental | Escalating doses of NXP900 given with osimertinib Receives: Drug: NXP900; Drug: Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
Measured: Up to 30 days post treatment
Objective response rate (ORR)
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Measured: 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.
Measured: Up to approximately 12 months
Disease Control Rate (DCR)
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).
Measured: Up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start18 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutation Positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuvectis Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zofia Piotrowska, MD, MHS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315113
- Sponsor's protocol ID
- NXP900-103
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Clinical Study of NXP900 in Combination With Osimertinib in Subjects With Advanced, EGFRMut+ Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07315113
- Acronym / sponsor ID
- NXP900-103
- Conditions
- EGFR Mutation Positive Non-small Cell Lung Cancer, EGFR Mutated Non-small Cell Lung Cancer Patients
- Keywords
- EGFR, Epidermal growth factor receptor, NSCLC, non-small cell lung cancer, lung cancer, osimertinib, NXP900, EGFR mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Nuvectis Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Exploration (Part 1) | Experimental | Drug: NXP900, Drug: OsimertinibEscalating doses of NXP900 given with osimertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provide written informed consent.
- 18 years old or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Unresectable, metastatic or locally advanced EGFR-mutated NSCLC.
- Prior treatment with osimertinib as first or second line, as single agent or in combination with chemotherapy, in the metastatic or locally advanced setting.
Key exclusion criteria (4 listed)
- Subject's cancer has a known oncogenic driver alteration other than EGFR.
- Known EGFR mutations that cause resistance to osimertinib
- Known human epidermal growth factor receptor 2 (HER2) overexpression
- Any contraindications to treatment with osimertinib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NXP900NXP900 is an orally administered inhibitor of SRC family kinases (SFK) | Drug | Dose Exploration (Part 1) |
| OsimertinibOsimertinib is an orally available, irreversible, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor | Drug | Dose Exploration (Part 1) |
Primary outcome
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
Time frame: Up to 30 days post treatment
Objective response rate (ORR)
Time frame: Up to approximately 12 months
Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Duration of Response (DoR)
Time frame: 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)
Time frame: Up to approximately 12 months
The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shay Shemesh contact
Zofia Piotrowska, MD, MHS principal investigator
Massachusetts General Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NXP900 and Osimertinib in people with EGFR Mutation Positive Non-small Cell Lung Cancer and EGFR Mutated Non-small Cell Lung Cancer Patients, run by Nuvectis Pharma, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Belshaw (12016278129, ebelshaw@nuvectis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with treatment related adverse events and/or clinical laboratory abnormalities (time frame: Up to 30 days post treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.