A Study of Sotorasib (AMG 510) in Participants With Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line Treatment
← catalyst calendarSponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 2
Status
Terminated
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
42actual
Sites
67
Countries
Belgium, Denmark, France +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Futility
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-01-28 | actual | When the study began enrolling |
| Primary completion | 2025-05-28 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-28 | actual | The whole study's end, after follow-up |
| First posted | 2021-06-22 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-13 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-small Cell Lung Cancer
Intervention
- Drug: Sotorasib — also filed as AMG 510, LUMYKRAS, LUMAKRAS
Primary outcome
what the primary-completion date above is the date OFObjective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
measured From the first dose of trial drug until min (last dose + 30 days, end of trial [EOT]); median [min, max] duration was 5.32 [0.8, 30.9] months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2022-02-25 · 3.1 MB · Prot_004.pdf
Statistical Analysis Planposted 2025-06-20 · 777 KB · SAP_005.pdf
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