NCT05198934

Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator's Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).

Conditions

• Colorectal Cancer (CRC)

Interventions

Type	Name	Description
DRUG	Sotorasib	Sotorasib will be administered orally
DRUG	Panitumumab	Panitumumab will be administered as intravenous (IV) infusion
DRUG	Trifluridine and Tipiracil	Trifluridine and Tipiracil will be administered orally
DRUG	Regorafenib	Regorafenib will be administered orally

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-07-16
• Completion: 2026-05-14
• First posted: 2022-01-20
• Last updated: 2026-02-06

Locations

105 sites across 12 countries: United States, Australia, France, Germany, Greece, Italy, Japan, Mexico, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study