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Targeted Therapy
Sotorasib for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Led By Sukhmani K Padda
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have received at least one line of systemic treatment for stage IV or recurrent NSCLC
Participants must have progressed following the most recent line of systemic therapy for NSCLC
Must not have
Participants who have received strong inducers of CYP3A4 within 14 days prior to sub-study registration and are planning to use strong inducers of CYP3A4 throughout protocol treatment
Participants who have received prior AMG 510 or other KRAS^G12C specific inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Summary
This trial studies the effect of AMG 510 in treating patients with KRAS G12C mutated non-squamous non-small cell lung cancer.
Who is the study for?
This trial is for adults with advanced non-squamous non-small cell lung cancer that has a specific KRAS G12C mutation and has worsened after treatment. They must have had at least one systemic therapy, be able to swallow pills, not be pregnant or nursing, and agree to use contraception if applicable. People with certain heart conditions, other cancers, or those who can't take the study drug due to interactions are excluded.Check my eligibility
What is being tested?
The trial is testing AMG 510 (Sotorasib), which targets the KRAS G12C mutation in stage IV or recurrent lung cancer. It's a phase II study aiming to see if this targeted treatment can stop tumor growth by focusing on this specific genetic change found in some tumors.See study design
What are the potential side effects?
While the exact side effects of AMG 510 are not detailed here, similar targeted therapies often cause diarrhea, fatigue, liver issues like elevated enzymes indicating liver stress or damage, skin problems such as rash and dry skin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one treatment for stage IV or recurrent non-small cell lung cancer.
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My NSCLC has worsened after the latest treatment.
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My lung cancer has a specific KRAS mutation identified by a genomic test.
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My cancer has specific genetic changes and has worsened despite treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken strong CYP3A4 inducers in the last 14 days and won't during the study.
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I have previously taken AMG 510 or a similar drug for KRASG12C mutation.
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I had major surgery less than 2 weeks ago and haven't fully recovered.
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I do not have severe heart problems, recent heart attacks, or uncontrolled irregular heartbeats.
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I plan to receive other cancer treatments while participating in this study.
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I have taken and plan to continue taking medication that is sensitive to CYP3A4 enzyme.
Select...
I don't have another cancer that could affect this treatment's safety or results.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate (confirmed, complete or partial)
Secondary outcome measures
Duration of response
Incidence of adverse events
Overall survival
+1 moreSide effects data
From 2022 Phase 1 trial • 20 Patients • NCT0488706420%
Electrocardiogram qt prolonged
20%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Severe Hepatic Impairment
Moderate Hepatic Impairment
Normal Hepatic Function
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (AMG 510)Experimental Treatment1 Intervention
Patients receive AMG 510 PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotorasib
FDA approved
Find a Location
Who is running the clinical trial?
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
261,145 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
395 Previous Clinical Trials
265,032 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,285 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (AMG 510)
Awards:
This trial has 2 awards, including:- 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.
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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