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Sotorasib for Non-Small Cell Lung Cancer
Study Summary
This trial studies the effect of AMG 510 in treating patients with KRAS G12C mutated 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.Trial Design
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Who is running the clinical trial?
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- I haven't taken strong CYP3A4 inducers in the last 14 days and won't during the study.My brain or spinal metastases have been treated and stable for at least a week.My cancer can be measured on a CT or MRI scan taken within the last 28 days.I have a stomach or intestine condition that affects how medicines work in my body.I have had at least one treatment for stage IV or recurrent non-small cell lung cancer.I haven't had radiation therapy in the last 14 days, except for brain metastases treatment which was over a week ago.I have leptomeningeal disease but no symptoms, only found through imaging.I have previously taken AMG 510 or a similar drug for KRASG12C mutation.I had major surgery less than 2 weeks ago and haven't fully recovered.I do not have severe heart problems, recent heart attacks, or uncontrolled irregular heartbeats.I have had a brain scan within the last 42 days.My NSCLC has worsened after the latest treatment.I have not had any cancer treatment in the last 3 weeks.I have stable neurological issues from cancer in my brain or spine and am on a reducing dose of steroids.I plan to receive other cancer treatments while participating in this study.I have mostly recovered from previous cancer treatment side effects.My lung cancer is advanced or has come back and is mostly non-squamous.I have taken and plan to continue taking medication that is sensitive to CYP3A4 enzyme.My lung cancer has worsened after the latest treatment.I can make decisions for myself or, if not, my condition still allows safe study participation.My lung cancer has a specific KRAS mutation identified by a genomic test.I had a physical exam within the last 28 days.I am fully active or restricted in physically strenuous activity but can do light work.You need to have certain blood test results within 28 days before joining the study.I can join the study even if I need help making decisions, as long as I'm safe to participate.If you have HIV, the virus must not be detectable in your most recent test within the last 6 months.My cancer has specific genetic changes and has worsened despite treatment.I don't have another cancer that could affect this treatment's safety or results.
- Group 1: Treatment (AMG 510)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Are there any vacancies available in this research endeavor?
"As indicated on clinicaltrials.gov, this experiment is actively seeking out volunteers and the most recently updated version was published 11/9/2022 since its initial posting of 4/16/2021."
In how many settings is this research trial being conducted?
"This trial has amassed a total of 100 participants amongst Essentia Health Sandstone in Sandstone, Providence Portland Medical Center in Portland, and Kaiser Permanente Northwest in Columbus. In addition to these three sites, there are many more enrolling patients across the country."
For which medical conditions is the drug Sotorasib typically prescribed?
"Sotorasib is frequently prescribed to patients who previously underwent platinum-based therapy. It can also be used in therapeutic procedures, after one systemic treatment, and as part of a malignant neoplasm management plan."
Is this investigation a pioneering effort in its field?
"Amgen-sponsored trials for Sotorasib have been taking place since 2018, with 5 studies already having reached completion. Currently, there are 11 active experiments running in 28 countries and 632 cities that involve 713 patients all together."
How many participants are enrolled in the current clinical trial?
"This clinical trial necessitates the enrolment of 116 patients that match its predetermined eligibility criteria. Potential participants can be located at Essentia Health Sandstone in Minnesota and Providence Portland Medical Center, Oregon."
Have any other investigations been conducted regarding Sotorasib?
"Currently, 11 trials are evaluating the effects of Sotorasib with 1 trial in its concluding phase. The majority of these experiments take place in Sutton, Cataluña; however, there exists a total of 1376 clinical research sites dedicated to this drug's efficacy."
What is the risk profile of Sotorasib for individuals?
"Sotorasib's safety has been assessed and given a score of 2 on the 1-3 scale. This is because this Phase 2 trial only possesses preliminary proof that it can be safely administered, with no evidence yet indicating its efficacy."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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