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

Nuvectis Pharma

Status and phase: Enrolling; Phase 1

Conditions: EGFR Mutation Positive Non-small Cell Lung Cancer; EGFR Mutated Non-small Cell Lung Cancer Patients

Treatments: Drug: NXP900; Drug: Osimertinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07315113

NXP900-103

Details and patient eligibility

About

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)

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Dose Exploration (Part 1)

Experimental group

Description:

Escalating doses of NXP900 given with osimertinib

Treatment:

Drug: Osimertinib

Drug: NXP900