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ALK Inhibitors for Non-Small Cell Lung Cancer
Study Summary
This trial is studying a combination of biomarker/ALK inhibitors to treat patients with stage IV ALK positive non-squamous 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.Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT01005680Trial Design
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Who is running the clinical trial?
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- I do not have serious heart problems like uncontrolled high blood pressure or recent heart attacks.I am not on medications that would interfere with the study drug.I have brain metastases but also have a measurable cancer lesion outside the brain.I have ongoing or repeated pancreatitis confirmed by tests.I have brain metastases but no symptoms, or they are treated, and I have stable health.I can take care of myself and am up and about more than half of my waking hours.I do not have any serious illness or organ problems that could affect my safety or the study.I haven't had major surgery in the last 2 weeks, but minor procedures are okay.Your platelet count is at least 100,000 cells per cubic millimeter within the last 28 days before joining the study.I completed my short radiation therapy over 2 days ago, and any brain or whole body radiation over 1 to 2 weeks ago.My lung cancer is ALK-positive and at stage IV.I can swallow pills whole.I have not received chemotherapy or immunotherapy after my initial registration.Your liver enzyme levels are not too high, unless you have cancer that has spread to your liver.I am willing to have a new biopsy or use a recent one if it's available.Your white blood cell count is at least 1500 cells per cubic millimeter.I have only ALK-positive non-squamous NSCLC and no other cancers in the last 2 years, except for certain treated or in remission cancers.I am not pregnant or breastfeeding and agree to use contraception or abstain from sex during the study.I do not have active inflammatory bowel disease or conditions affecting medication absorption.I've had only one chemotherapy session for my metastatic NSCLC without disease progression, or it's been over a year since my last adjuvant or neoadjuvant chemotherapy.Your AST levels in the blood should not be too high, unless you have liver metastases, in which case it can be a little higher but still within a certain limit.Your bilirubin levels are within a certain range, unless you have been diagnosed with Gilbert's syndrome.My cancer has worsened after treatment with one specific ALK inhibitor.I have never taken lorlatinib for my condition.My side effects from previous treatments are mild or gone, except for hair loss or hearing loss.I have taken a specific lung cancer medication within the last 5-7 days.I do not have any serious infections right now.My kidneys are functioning well, with a creatinine clearance rate of at least 60 mL/min.I have had lung conditions like pneumonitis or fibrosis, but not from radiation.
- Group 1: No ALK-resistance mutations
- Group 2: I1171
- Group 3: Compound mutation
- Group 4: F1174
- Group 5: G1202 (including G1202del and G1202R)
- Group 6: ALK L1198F mutation (alone or combination with ALK inhibitor)
- Group 7: V1180
- Group 8: C1156Y
- Group 9: MET amplification
- Group 10: L1196 (including L1196M)
- 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
Could you outline which other research initiatives have incorporated Pemetrexed?
"In 1997, the City of Hope Comprehensive Cancer Center initiated clinical trials examining pemetrexed. To date, 1936 studies have been finalized and 1324 additional investigations are yet to be completed; a large portion of these active experiments are based in Cape Girardeau, Missouri."
Are there any current opportunities to participate in this investigation?
"Clinicaltrials.gov reveals that this medical study is not currently recruiting patients, with its first post dating back to April 1st 2019 and its most recent update going as far back as September 23rd 2022. However, numerous other trials are actively enrolling participants at present - 3232 in total."
What risks do patients bear when taking Pemetrexed?
"Pemetrexed is estimated to be a safe drug, with an assigned score of 2. This classification reflects the fact that there is some evidence for its safety but no data has been collected on efficacy yet."
How many sites are currently involved in administering this research?
"This trial is taking place in 100 distinct sites, a few of which are located in Cape Girardeau, Honolulu and Springfield. To reduce the travel burden on participants, it is recommended to select the nearest clinic if enrolling."
How many volunteers have enrolled in this medical experiment?
"This particular trial is no longer attempting to recruit participants; its initial posting was April 1st 2019 and the latest update occurred on September 23rd 2022. Currently, there are 1908 studies admitting patients with stage IVA lung cancer ajcc v8 and 1324 trials taking partakers undergoing Pemetrexed treatment."
What ailments does Pemetrexed typically target?
"Pemetrexed is a go-to medication for treating advanced head and neck cancer. Additionally, its efficacy extends to malignant neoplasms, unresectable thymoma, and mesotheliomas."
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