A Phase II, Single Arm, Multicenter Study to Evaluate Anti-tumor Activity, Safety, Tolerability and Pharmacokinetics of DZD9008 in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with EGFR Exon 20 Insertion Mutation

Dizal Pharmaceuticals33 sites in 1 country104 target enrollmentJuly 19, 2021

ConditionsNon-Small Cell Lung Cancer

InterventionsSunvozertinib

DrugsSunvozertinib

Overview

Phase: Phase 2
Intervention: Sunvozertinib
Conditions: Non-Small Cell Lung Cancer
Sponsor: Dizal Pharmaceuticals
Enrollment: 104
Locations: 33
Primary Endpoint: Objective Response Rate (ORR) according to RECIST 1.1 by an Independent Review Committee (IRC)
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

This is a Phase II, single-arm, multi-center clinical study to evaluate the anti-tumor efficacy, safety, tolerability and pharmacokinetics of Sunvozertinib in participants with locally advanced or metastatic NSCLC carrying EGFR exon 20 insertion mutations whose disease has progressed on prior platinum-based chemotherapy

Registry

clinicaltrials.gov

Start Date

July 19, 2021

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dizal Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must be able to understand the nature of the trial and provide a signed and dated, written informed consent form.
•Aged at least 18 years old.
•Histological or cytological confirmed locally advanced or metastatic NSCLC
•Tumor tissue EGFR exon 20 insertion mutations confirmed by qualified local laboratories or sponsor-designated central laboratories.
•Participants must exhibit Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 at ICF signature with no deterioration over the past 2 weeks.
•Predicted life expectancy ≥ 12 weeks.
•Patient must have measurable disease according to RECIST 1.
•Patients with brain metastasis (BM) can only be enrolled under the condition that BM is previously treated and stable.
•Adequate organ system functions.
•Patients should receive at least one line but no more than three lines of prior systemic therapy (at least one line must contain platinum-based therapy).

Exclusion Criteria

•Prior malignancy within 2 years requires active treatment, except for adequately treated basal cell skin carcinoma, in situ cervical carcinoma, or other cancer types (to be discussed with Dizal's Study Physician) who has been disease free for \> 2 years with life expectancy \>2 years.
•Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting Sunvozertinib with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy.
•Spinal cord compression or leptomeningeal metastasis.
•History of stroke or intracranial hemorrhage within 6 months before first administration of Sunvozertinib.
•Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses.
•Active infection including hepatitis B, hepatitis C, human immunodeficiency virus (HIV) and COVID-
•Any of the following cardiac criteria:
•Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 electrocardiograms (ECGs).
•Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval \> 250 msec.
•Any factors that increase the risk of QTc prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval .