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Alkylating agents
Sotorasib + Chemotherapy for Lung Cancer
Phase 2
Recruiting
Led By Ferdinandos Skoulidis
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with disease stage IIA to select stage IIIB (T3-4N2)
Patients must be able to take oral medications and willing to record daily adherence to investigational product
Must not have
Male subjects unwilling to abstain from donating sperm during treatment
Infections requiring more than 5 days of parenteral antibiotics within 2 weeks prior to cycle 1 day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
This trial is for adults over 18 with stage IIA-IIIB non-squamous NSCLC, who haven't been treated before and have a KRAS p.G12C mutation. They must be fit for surgery, have good kidney function, an ECOG score of 0-1 (which means they're fully active or restricted in physically strenuous activity but can do light work), and no signs of stage IV cancer. Participants need to provide tissue samples, not be pregnant or breastfeeding, use effective contraception if applicable, and cannot have certain health issues that would interfere with the study.
What is being tested?
The trial tests sotorasib combined with cisplatin (or carboplatin) and pemetrexed as pre-surgery treatment for lung cancer patients. The goal is to see if this combination improves the rate at which tumors shrink compared to historical data on chemotherapy alone. Patients will receive four cycles of treatment including at least one dose of sotorasib.
What are the potential side effects?
Possible side effects include those common to chemotherapy like nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems; kidney function changes; allergic reactions; heart rhythm abnormalities due to QT interval prolongation; liver function alterations; and potential gastrointestinal issues affecting oral medication intake.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is between stages IIA and select IIIB.
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I can take pills and am willing to track my medication use daily.
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I can provide samples of my tumor or am willing to have a biopsy.
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My lung cancer is non-squamous and has not been treated before.
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My cancer has a specific KRAS mutation.
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I am older than 18 years.
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My kidneys are functioning well.
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I am mostly active and my doctor expects me to live more than 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I agree not to donate sperm during my treatment.
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I haven't needed strong antibiotics for infections in the last 2 weeks.
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I have not had major surgery in the last 4 weeks.
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I am a woman who can have children and my pregnancy test is positive.
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I am a woman able to have children and do not plan to use effective birth control.
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I do not have any serious or uncontrolled health issues.
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I cannot take pills due to a stomach or intestine problem.
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I have received cancer treatment or radiation for my current lung cancer.
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My lung cancer is mainly squamous cell type.
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My lung cancer is at an advanced stage (IIIB N3, IIIC, IVA, or IVB).
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I am a male with a pregnant partner and will not use a condom or abstain from sex.
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I have tested positive for HIV/AIDS.
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I am currently pregnant, breastfeeding, or planning to become pregnant.
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I have a serious heart condition.
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I have had lung inflammation or drug-related lung issues before.
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I am a man and will not use birth control or abstain from sex with my partner who can have children.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Sotorasib in Combination with Cisplatin/Carboplatin and PemetrexedExperimental Treatment4 Interventions
4 cycles of at least one dose of sotorasib plus cisplatin (or carboplatin) and pemetrexed can be administered safely
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG 510
2020
Completed Phase 1
~120
Cisplatin
2013
Completed Phase 3
~3120
Carboplatin
2014
Completed Phase 3
~6120
Pemetrexed
2014
Completed Phase 3
~5550
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,197 Total Patients Enrolled
AmgenIndustry Sponsor
1,433 Previous Clinical Trials
1,395,115 Total Patients Enrolled
Ferdinandos SkoulidisPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
47 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Sotorasib in Combination with Cisplatin/Carboplatin and Pemetrexed
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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