CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 160 enrolled
Drug / intervention
Sotorasib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05198934
NCT05198934Phase 3Completed
CompareCT.gov

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

Amgen·interventional·Posted Jan 20, 2022·Updated Apr 27, 2026

In Brief

A Phase 3 clinical trial evaluating Sotorasib, Panitumumab, and 2 other interventions for Colorectal Cancer (CRC). Completed, enrolled 160 participants across 105 sites in 12 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer (CRC)
CountriesAustralia, France, Germany, Greece, Italy, Japan, Mexico, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJan 20, 2022
Enrollment StartApr 19, 2022
Primary CompletionJul 16, 2025
Study CompletionApr 14, 2026
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 4.5 years ago

Interventions

Sotorasibdrug

Sotorasib will be administered orally

Panitumumabdrug

Panitumumab will be administered as intravenous (IV) infusion

Trifluridine and Tipiracildrug

Trifluridine and Tipiracil will be administered orally

Regorafenibdrug

Regorafenib will be administered orally