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

NCT05198934 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-27

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-19
Primary Completion
2025-07-16
Completion
2026-04-14
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Mexico
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198934 on ClinicalTrials.gov