A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: ZN-e4

• Registration Number: NCT03446417
• Lead Sponsor: Zeno Pharmaceuticals, Inc.

Brief Summary

This is a Phase 1/2, open-label, multicenter, sequential dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-e4 administered orally in subjects with advanced non-small cell lung cancer (NSCLC) with activating EGFR mutations who have progressed while on treatment with an EGFR tyrosine kinase inhibitor (TKI) agent (other lines of treatment are allowed, except for other epidermal growth factor receptor inhibitors \[EGFRis\]) for Phase 1; and for Phase 2, subjects who have T790M+ and are osimertinib naïve (Cohort 1), and also those who have not been treated with an EGFR Inhibitor (EGFRi) (Cohort2).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-26
• Study Start: 2018-04-20
• Primary Completion: 2022-01-17
• Study Completion: 2022-11-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 2	ZN-e4	MTD/RP2D in subjects: Cohort 1: with T790M mutation in epidermal growth factor receptor (EGFR) gene, and are osimertinib naïve. Cohort 2: EGFRm amenable to EGFR inhibitor therapy (eg, exon 19 del, L858R) and who have never been treated with EGFRis.
Phase 1	ZN-e4	Up to 9 sequential dose escalation cohorts to determine maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified.

Primary Outcome Measures

Name	Time	Method
Observed dose limiting toxicities	1 Cycle (21 days)

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability as measured by incidence of treatment emergent adverse events	Through study completion, approximately 2 years

Trial Locations

Locations (7)

Site 8; 🇧🇦 Banja Luka, Bosnia and Herzegovina

Site 7; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Site 5; 🇺🇸 Detroit, Michigan, United States

Site 2; 🇺🇸 Duarte, California, United States

Site 1; 🇺🇸 East Setauket, New York, United States

Site 6; 🇺🇸 Charlotte, North Carolina, United States

Site 3; 🇺🇸 Gettysburg, Pennsylvania, United States