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ALK Inhibitor

Ensartinib vs. Crizotinib for Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by Xcovery Holding Company, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Summary

This trial will compare the effectiveness of X-396 vs. crizotinib in treating ALK-positive non-small cell lung cancer.

Who is the study for?
Adults with advanced ALK-positive NSCLC, who can swallow pills and have good organ function. They must not be pregnant or breastfeeding, agree to use contraception, and can't have had certain recent treatments or heart issues. Only one prior chemo regimen is allowed.
What is being tested?
The trial compares the effectiveness of a new drug called Ensartinib (X-396) against Crizotinib in treating ALK-positive NSCLC patients who've had limited previous chemotherapy but no prior ALK inhibitors.
What are the potential side effects?
Possible side effects include digestive problems that could affect how drugs are absorbed, liver enzyme changes indicating potential liver damage, blood cell count variations which might lead to infection risk or bleeding issues, and heart rhythm abnormalities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free survival (PFS)
Secondary study objectives
CNS response rate
ORR based on independent radiology review
Overall survival (OS)
Other study objectives
CNS response rate based on investigator assessment
Duration of Response based on investigator assessment and independent radiology review
ORR based on investigator assessment
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: X-396 (ensartinib)Experimental Treatment1 Intervention
Eligible patients with ALK+ NSCLC will receive oral X-396 (ensartinib) at 225mg QD with or without food until progression or unacceptable toxicity develops
Group II: crizotinibActive Control1 Intervention
Eligible patients with ALK+ NSCLC will receive oral crizotinib at 250mg BID with or without food until progression or unacceptable toxicity develops

Find a Location

Who is running the clinical trial?

Xcovery Holding Company, LLCLead Sponsor
8 Previous Clinical Trials
240 Total Patients Enrolled
Xcovery Holdings, Inc.Lead Sponsor
9 Previous Clinical Trials
328 Total Patients Enrolled
Giovanni Selvaggi, MDStudy ChairCEO
1 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Crizotinib (ALK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02767804 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: crizotinib, X-396 (ensartinib)
Non-Small Cell Lung Cancer Clinical Trial 2023: Crizotinib Highlights & Side Effects. Trial Name: NCT02767804 — Phase 3
Crizotinib (ALK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02767804 — Phase 3
~36 spots leftby Dec 2025