Recruiting
Phase 1

NXP900 & Osimertinib

Sponsor:

Nuvectis Pharma, Inc.

Code:

NCT07315113

Conditions

EGFR Mutation Positive Non-small Cell Lung Cancer

EGFR Mutated Non-small Cell Lung Cancer Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NXP900

Osimertinib

Study Details

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)

Conditions

EGFR Mutation Positive Non-small Cell Lung Cancer

EGFR Mutated Non-small Cell Lung Cancer Patients

Study ID

NCT07315113

Start date

Dec 18, 2025

Status verified date

Jul, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

18 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Exploration (Part 1)

Escalating doses of NXP900 given with osimertinib

Interventions

NXP900

NXP900 is an orally administered inhibitor of SRC family kinases (SFK)

Osimertinib

Osimertinib is an orally available, irreversible, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor

Primary outcome measure

  • 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 ]
  • Duration of Response (DoR) [ Time Frame: Up to approximately 12 months ]
  • Disease Control Rate (DCR) [ Time Frame: Up to approximately 12 months ]

Central Contacts and Locations

Central contacts

Erin Belshaw

12016278129ebelshaw@nuvectis.com

Shay Shemesh

sshemesh@nuvectis.com

Locations

Maryland Oncology Hematology

Recruiting

Calverton, Maryland, United States, 20705

Willamette Valley Cancer Institute and Research Center

Recruiting

Eugene, Oregon, United States, 97401

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

NEXT Houston

Recruiting

Houston, Texas, United States, 77054

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Nuvectis Pharma, Inc.

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Keywords

  • EGFR
  • Epidermal growth factor receptor
  • NSCLC
  • non-small cell lung cancer
  • lung cancer
  • osimertinib
  • NXP900
  • EGFR mutation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nuvectis Pharma, Inc. on 2026-07-09.