NCT04303780

Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Conditions

• KRAS p, G12c Mutated /Advanced Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	AMG 510	21 day cycles
DRUG	Docetaxel	21 day cycles

Timeline

• Start date: 2020-06-04
• Primary completion: 2022-08-02
• Completion: 2026-05-29
• First posted: 2020-03-11
• Last updated: 2026-03-27
• Results posted: 2023-05-10

Locations

274 sites across 23 countries: United States, Australia, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study