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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
Pivotal Trial
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
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 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tumors in your brain or spinal cord covering.You are allergic to tartrazine, a dye used in the ensartinib 100 mg capsule.You are taking certain medications that can interact with the study drug.You have a high risk for a hole in your digestive system.You have a heart condition that may cause irregular heartbeats or high blood pressure that is not well controlled.You are able to perform everyday activities without any problems or with only a little difficulty.You can swallow and keep down pills or liquid medicine.You have taken certain medications for your cancer in the past, or you are currently receiving any type of cancer treatment.You must have a measurable disease according to specific medical guidelines.You have been diagnosed with advanced or recurrent non-small cell lung cancer, and a specific test shows that you have a certain gene mutation.You are currently using herbal medications for cancer treatment.You had cancer in the last 3 years, except for some specific types that were treated and are not expected to affect the study.You have a serious infection, lung disease, or other medical condition that could make it hard for you to get the treatment.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.Your blood counts, liver, and kidney function must be within certain levels. If you have brain metastases, they must not cause any symptoms at the start of the study.You have heart problems that are not controlled with medication, or you have had a heart attack or stroke within the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: crizotinib
- Group 2: X-396 (ensartinib)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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