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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
Must not have
Gastrointestinal (GI) tract disease causing the inability to take oral medication
Myocardial infarction within 6 months of study day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated up to 6 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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
Select...
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot take pills due to a stomach or intestine problem.
Select...
I have not had a heart attack in the last 6 months.
Select...
I have active cancer spread to my brain.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS)
Secondary study objectives
Area under the plasma concentration-time curve (AUC)
Disease control rate (DCR)
Duration of response (DOR)
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,433 Previous Clinical Trials
1,394,797 Total Patients Enrolled
MDStudy DirectorAmgen
971 Previous Clinical Trials
938,969 Total Patients Enrolled

Media Library

AMG 510 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04303780 — Phase 3
Lung Cancer Research Study Groups: AMG 510, Docetaxel
AMG 510 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04303780 — Phase 3
~64 spots leftby Nov 2025
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