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Small Molecule

AMG 510 for Non-Small Cell Lung Cancer

Phase 3

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG ≤ 1

Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through central testing or have documentation of KRAS p.G12C mutation through Amgen Study 20190294 prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up estimated up to 6 years

Awards & highlights

Study Summary

This trial is testing a new drug, AMG 510, to see if it works better than the current standard of care drug, docetaxel, in treating NSCLC patients with a specific KRAS mutation.

Who is the study for?

This trial is for adults over 18 with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that has a specific KRAS p.G12C mutation. Participants should have an ECOG performance status of ≤1, indicating they are relatively active. They can't join if they have active brain tumors, recent heart attacks, or GI diseases preventing oral medication intake.Check my eligibility

What is being tested?

The study compares AMG 510 (Sotorasib), a new treatment option, to Docetaxel, an established chemotherapy drug in patients with NSCLC who carry the KRAS p.G12c mutation and have been previously treated.See study design

What are the potential side effects?

AMG 510 may cause liver issues, diarrhea, muscle and joint pain. Docetaxel can lead to low blood cell counts increasing infection risk, allergic reactions during infusion, hair loss, nail changes and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all my pre-disease activities without restriction.

Select...

My advanced lung cancer has a specific KRAS mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~estimated up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated up to 6 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

Progression-free Survival (PFS)

Secondary outcome measures

Area under the plasma concentration-time curve (AUC)

Disease control rate (DCR)

Duration of response (DOR)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AMG 510Experimental Treatment1 Intervention

Group II: DocetaxelActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AMG 510

2020

Completed Phase 1

~120

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,370 Previous Clinical Trials

1,377,343 Total Patients Enrolled

MDStudy DirectorAmgen

913 Previous Clinical Trials

923,786 Total Patients Enrolled

Media Library

AMG 510 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04303780 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: AMG 510, Docetaxel

AMG 510 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04303780 — Phase 3

Frequently Asked Questions

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

What are the approved medical uses for AMG 510?

"AMG 510 is commonly used to treat head conditions. It can also be effective in treating other issues like one prior systemic therapy, soft tissue sarcoma (sts), and brca1 gene."

Answered by AI

Are there risks involved with using AMG 510?

"There is both preclinical and clinical data supporting the safety of AMG 510, which gives it a score of 3."

Answered by AI

Could you provide the aggregate number of individuals enrolled in this experimental procedure?

"This specific trial is no longer looking for participants. It was initially posted on June 4th, 2020 but the listing was last edited on November 10th, 2022. With that being said, there are currently 1,391 trials actively recruiting patients with non-small cell lung carcinoma and 346 for AMG 510."

Answered by AI

Does this research project have an age limit for participants?

"Eligible participants for this particular clinical trial must be aged 18 to 100. There are 34 clinical trials recruiting patients that are younger than 18 and 1727 studies searching for volunteers above the age of 65."

Answered by AI

How can I sign up to participate in this research?

"Up to 345 patients that meet the age requirement of 18-100 and have non-small cell lung carcinoma will be accepted into this study. There are a few other requirements, including being male or female and having an ECOG score of 1 or lower."

Answered by AI

Are medical professionals currently enrolling new patients for this trial?

"This particular trial, which was last updated on November 10th 2022 is not actively recruiting patients. However, there are over 1700 other medical studies that are presently looking for volunteers."

Answered by AI

Could you please list any other research that has been conducted utilizing AMG 510?

"Presently, there are 346 clinical trials underway for AMG 510. Of these, 132 are in Phase 3. Most of the AMG 510 trials are originating from Fuzhou, Fujian; however, there 24090 research centres running similar studies."

Answered by AI

Is this clinical trial being run in multiple states?

"This study has many open slots at The Ottawa Hospital Cancer Centre, Florida Cancer Specialists - Fort Myers, Valley Cancer Associates and other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

2020. "Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04303780.

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