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Lorlatinib for Non-Small Cell Lung Cancer
Study Summary
This trial is testing whether lorlatinib is safe and effective for people with lung cancer that has progressed after treatment with alectinib or ceritinib.
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.Side effects data
From 2020 Phase 1 trial • 29 Patients • NCT03542305Trial Design
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Who is running the clinical trial?
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- I haven't had any cancer other than my current NSCLC or certain low-risk types in the last 3 years.I haven't had radiation therapy (except for bone pain relief) in the last 2 weeks.I am fully active or can carry out light work.My lung cancer is stage IV with an ALK rearrangement.I have a measurable tumor outside the brain and may have stable brain metastases.I have had radiation to more than a quarter of my bone marrow.My cancer progressed after first-line treatment with alectinib or ceritinib.Any side effects from my previous treatments are mild or gone.I do not have any serious infections like HBV, HCV, HIV, or AIDS.My heart's pumping ability is below normal according to tests.I haven't had serious heart or blood vessel problems in the last 3 months.I have previously been treated with ALK inhibitors other than alectinib or ceritinib.I have not had major surgery in the last 4 weeks.You have traits that could make you more likely to get acute pancreatitis, as determined by the researchers.I have a history of lung scarring or inflammation.I haven't taken specific strong medications or certain foods that affect drug metabolism in the last 12 days.I have spinal cord compression but have stable pain and neurological function for the last 4 weeks.I am not pregnant or breastfeeding and agree to use contraception during and after the study.I am a male and agree to use contraception during and for 98 days after the study.I do not have major stomach or bowel problems that affect how I eat or absorb food.My bone marrow, pancreas, kidneys, and liver are all working well.I stopped taking alectinib or ceritinib long enough before starting lorlatinib.
- Group 1: Lorlatinib
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
To what extent has Lorlatinib been tested in clinical research?
"Lorlatinib was initially evaluated in 2016 at Ziekehuisgroep Twente. Since that time, 12 trials have been concluded and 16 active studies are underway; a great many of them occurring within Athens, Georgia."
Does Lorlatinib carry any risks for those using it therapeutically?
"With a score of 3, Lorlatinib has been deemed relatively safe due to its elevated Phase 4 status which implies that the drug is approved for public use."
Does this research endeavor represent a pioneering effort?
"Currently, 16 clinical studies related to Lorlatinib are recruiting patients across 432 cities and 26 nations. Janssen LP initiated the first trial in 2016; this Phase 2 study involved 1550 volunteers and was concluded with drug approval. Subsequently, an additional 12 trials have been conducted since then."
How many participants is the research team recruiting for this clinical trial?
"Affirmative. Clinicaltrials.gov data verifies that this scientific inquiry, which was first published on October 8th 2020, is currently looking for subjects to enrol. 85 patients are required from 2 distinct trial sites."
Does this trial still offer the opportunity for patients to enroll?
"According to clinicaltrials.gov, recruitment is currently ongoing for this trial which was first made available on October 8th 2020 and the most recent update occurred on November 17th 2022."
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