Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer

NCT07315113 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NXP900-103
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Dose Exploration (Part 1)

EXPERIMENTAL

Escalating doses of NXP900 given with osimertinib

Drug: NXP900; Drug: Osimertinib

Interventions

NXP900 DRUG

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

Dose Exploration (Part 1)

Osimertinib DRUG

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

Dose Exploration (Part 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuvectis Pharma, Inc.: lead

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

NEXT Houston

Houston, Texas, 77054, United States

RECRUITING

NEXT Virginia

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zofia Piotrowska, MD, MHS

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Belshaw

CONTACT

12016278129; ebelshaw@nuvectis.com

Shay Shemesh

CONTACT

sshemesh@nuvectis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)