Clinical Trial: NCT04303780
Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2026-07-22 |
Study Overview
Brief Summary
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Official Title
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
Conditions
KRAS p, G12c Mutated /Advanced Metastatic NSCLC
Intervention / Treatment
- Drug: AMG 510
- Drug: Docetaxel
Other Study ID Numbers
- 20190009
- 2023-508214-42-00
- 2023
Start Date (Actual)
2020-06-04
Primary Completion Date (Actual)
2022-08-02
Study Completion Date (Actual)
2026-06-24
Enrollment (Actual)
345
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2026-07-22 |
Study Overview
Brief Summary
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Official Title
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
Conditions
KRAS p, G12c Mutated /Advanced Metastatic NSCLC
Intervention / Treatment
- Drug: AMG 510
- Drug: Docetaxel
Other Study ID Numbers
- 20190009
- 2023-508214-42-00
- 2023
Start Date (Actual)
2020-06-04
Primary Completion Date (Actual)
2022-08-02
Study Completion Date (Actual)
2026-06-24
Enrollment (Actual)
345
Study Type
Interventional
Phase
Phase 3