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Ensartinib vs. Crizotinib for Non-Small Cell Lung Cancer
Study Summary
This trial will compare the effectiveness of X-396 vs. crizotinib in treating ALK-positive non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: crizotinib
- Group 2: X-396 (ensartinib)
- 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.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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