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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
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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 below
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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:
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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.
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I don't have another cancer that could affect this treatment's safety or results.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Duration of response
Incidence of adverse events
Overall survival
+1 more

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064
14%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Normal Hepatic Function
Moderate Hepatic Impairment
Severe Hepatic Impairment

Awards & Highlights

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.

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
261,071 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
266,486 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,922 Total Patients Enrolled

Media Library

Sotorasib (Targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04625647 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Treatment (AMG 510)
Non-Small Cell Lung Cancer Clinical Trial 2023: Sotorasib Highlights & Side Effects. Trial Name: NCT04625647 — Phase 2
Sotorasib (Targeted Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04625647 — Phase 2
~43 spots leftby Dec 2026
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