AMG 510 for Non-Small Cell Lung Cancer
Recruiting at 289 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Amgen
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Research Team
M
MD
Principal Investigator
Amgen
Eligibility Criteria
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.Inclusion Criteria
I am fully active and can carry on all my pre-disease activities without restriction.
My advanced lung cancer has a specific KRAS mutation.
I am 18 years old or older.
Exclusion Criteria
I cannot take pills due to a stomach or intestine problem.
I have not had a heart attack in the last 6 months.
I have active cancer spread to my brain.
Treatment Details
Interventions
- AMG 510 (Small Molecule)
- Docetaxel (Taxane)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: AMG 510Experimental Treatment1 Intervention
Group II: DocetaxelActive Control1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London