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

ConditionsEGFR Mutation Positive Non-small Cell Lung CancerEGFR Mutated Non-small Cell Lung Cancer Patients
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuvectis Pharma, Inc.

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Sequential

Treatments tested in this trial

  • NXP900

    Drug

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

  • Osimertinib

    Drug

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

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Dose Exploration (Part 1)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of patients with treatment related adverse events and/or clinical laboratory abnormalities

Time frame
Up to 30 days post treatment
2

Objective response rate (ORR)

Best response of complete response (CR) or partial response (PR) per RECIST 1.1

Time frame
Up to approximately 12 months
3

Duration of Response (DoR)

Confirmed CR or PR from the first documented response to the date of documented disease progression or death.

Time frame
Up to approximately 12 months
4

Disease Control Rate (DCR)

The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).

Time frame
Up to approximately 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nuvectis Pharma, Inc.

Lead sponsor

Source ClinicalTrials.gov
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