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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 with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study registration
Participants must have measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days prior to sub-study registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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 below
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My brain or spinal metastases have been treated and stable for at least a week.
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My cancer can be measured on a CT or MRI scan taken within the last 28 days.
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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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I have had a brain scan within the last 42 days.
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My NSCLC has worsened after the latest treatment.
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I have mostly recovered from previous cancer treatment side effects.
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My lung cancer is advanced or has come back and is mostly non-squamous.
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My lung cancer has a specific KRAS mutation identified by a genomic test.
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I had a physical exam within the last 28 days.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can join the study even if I need help making decisions, as long as I'm safe to participate.
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My cancer has specific genetic changes and has worsened despite treatment.

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

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 more

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
261,695 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
394 Previous Clinical Trials
265,054 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,037 Total Patients Enrolled

Media Library

Sotorasib (Targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04625647 — Phase 2
Lung Cancer Research Study Groups: Treatment (AMG 510)
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
California Pacific Medical Center-Pacific Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
~55 spots leftby Dec 2026