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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
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.
Ability to swallow and retain oral medication.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are able to perform everyday activities without any problems or with only a little difficulty.
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You can swallow and keep down pills or liquid medicine.
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You have only had one round of chemotherapy for your advanced cancer, and this includes any ongoing treatment. If you had chemotherapy before your cancer spread, and it came back within six months of finishing that treatment, it also counts as one round of chemotherapy for your advanced cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) as assessed by independent radiology review based on RECIST v. 1.1 criteria
Secondary outcome measures
CNS response rate based on independent radiology review
ORR based on independent radiology review
Overall survival (OS)
+1 more
Other outcome measures
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have other research groups looked at this same topic before?

"X-396 (ensartinib) has been under research since 2011 when it was first studied by Pfizer. In total, there have been 37 clinical trials concerning X-396 (ensartinib), which are being conducted across 1208 cities and 36 countries."

Answered by AI

Are there different sites where this research is being conducted around the state?

"Patients can enroll at Kaiser Permanente Hawaii- Moanalua Medical Center in Honolulu, Hawaii, Saint Alphonsus Regional Medical Center in Boise, Idaho, and Infirmière recherche Clinique, IUCPQ in Quebec City, Quebec as well as other sites 15 other locations."

Answered by AI

Are patients currently being accepted into this trial program?

"This particular study is not currently enrolling patients, as the last edit was made on October 21st, 2022. However, there are 37 other clinical trials involving X-396 (ensartinib) that are currently looking for participants. Additionally, 1999 other trials concerning carcinoma and non-small-cell lung cancer are also recruiting patients."

Answered by AI

Is X-396 (ensartinib) a new medication or has it been studied before?

"As of right now, there are 37 different ongoing clinical trials researching X-396 (ensartinib). Out of those active investigations, 6 have progressed to Phase 3. Most studies for X-396 (ensartinib) are taking place in Mountain View, California; however, across the world there are 7060 locations running trials for this medication."

Answered by AI

How many people are being treated as part of this clinical research?

"Enrollment for this study is no longer open. The trial was first posted on June 1st, 2016 and last updated on October 21st, 20202. However, there are 37 other trials involving X-396 (ensartinib) that are recruiting patients right now."

Answered by AI

Are there any short or long term dangers associated with taking X-396?

"There is some evidence, from both efficacy and safety trials, to support the use of X-396 (ensartinib). It received a score of 3."

Answered by AI
~33 spots leftby Mar 2025