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Sotorasib + Chemotherapy for Lung Cancer
Study Summary
This trial is testing a new way to treat non-squamous NSCLC that has a KRAS p.G12C mutation. The new treatment is neoadjuvant sotorasib in combination with cisplatin (or carboplatin) and pemetrexed chemotherapy. The goal is to see if this new treatment is safe and results in an improved MPR rate (meaning the tumor shrinks) compared to the historical control MPR rate for platinum-based chemotherapy alone.
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 agree not to donate sperm during my treatment.My cancer is between stages IIA and select IIIB.I haven't needed strong antibiotics for infections in the last 2 weeks.I can take pills and am willing to track my medication use daily.My blood and liver tests are within normal ranges.My scans do not show clear signs of stage IV disease.I have not had major surgery in the last 4 weeks.I am a woman who can have children and my pregnancy test is positive.I do not have any serious or uncontrolled health issues.I am a woman able to have children and do not plan to use effective birth control.I can provide samples of my tumor or am willing to have a biopsy.I have had cancer before, but it fits the trial's exceptions.I cannot take pills due to a stomach or intestine problem.I have received cancer treatment or radiation for my current lung cancer.You use illegal drugs regularly or have a history of substance abuse in the past year.Things like emotions, family situation, where you live, or other factors that might make it hard for you to follow the study rules and schedule.I had blood cancer but have been free of it for 2 years or more.My lung cancer is mainly squamous cell type.My lung cancer is non-squamous and has not been treated before.My lung cancer is at an advanced stage (IIIB N3, IIIC, IVA, or IVB).I am a male with a pregnant partner and will not use a condom or abstain from sex.My cancer has a specific KRAS mutation.I have tested positive for HIV/AIDS.I have not received a live vaccine in the last 30 days.I am currently pregnant, breastfeeding, or planning to become pregnant.I am older than 18 years.I am considered fit for surgery.My kidneys are functioning well.I have a serious heart condition.I am mostly active and my doctor expects me to live more than 3 months.You have a severe illness or another serious health condition.You have tested positive for hepatitis B or C virus.I have had lung inflammation or drug-related lung issues before.The time it takes for your heart to recover after each beat is within a certain range.I am a man and will not use birth control or abstain from sex with my partner who can have children.Your disease can be measured using specific guidelines called RECIST 1.1.People who are in prison or have trouble remembering things are not able to participate.
- Group 1: Sotorasib in Combination with Cisplatin/Carboplatin and Pemetrexed
- 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 opportunities for interested participants to join this research endeavor?
"This clinical trial is currently in the recruitment phase, with information posted on clinicaltrials.gov indicating that it was initially shared on March 30th 2022 and amended lastly on October 10th of 2021."
What other data has been generated regarding AMG 510's efficacy?
"Currently, there are 1174 active clinical trials evaluating the efficacy of AMG 510. Of those trials, 388 studies have reached Phase 3 and many of them reside in Shanghai. Across 68041 locations worldwide, research is being conducted on this drug candidate."
Has the FDA given permission for AMG 510 to be used?
"Our team at Power determined that AMG 510 is relatively safe, rating it a 2. This Phase 2 trial has preliminary evidence indicating its safety but no data on efficacy yet."
How many participants are currently included in this research study?
"Affirmative. The clinical trial database, which was initially posted on March 30th 2022, indicates that the study is actively looking for 27 volunteers across 1 centre."
What medicinal applications does AMG 510 usually serve?
"AMG 510 is an accepted treatment for melanoma and has also been seen to ameliorate metastatic urothelial carcinoma, lymphomas of the non-Hodgkin variety, and other diseases that have previously responded to systemic therapies."
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