The Absolute Effect / Oncology Evidence / Evidence Index
CodeBreaK 200
After platinum chemotherapy and immunotherapy for KRAS G12C-mutated NSCLC, does sotorasib improve progression-free survival over docetaxel?
Registry: NCT04303780 · Evidence reviewed 9 November 2026 · Aliases and follow-up publications consolidated.
Phase III open-label randomized; n=345.Primary-source evidence summaryStudy design, population and eligibility
Phase III open-label randomized; n=345.
KRAS G12C advanced NSCLC after platinum chemotherapy and PD-(L)1 inhibitor.
Treatment and comparator
Intervention: Sotorasib 960 mg daily.
Comparator: Docetaxel 75 mg/m² q3 weeks.
Endpoints
PFS by BICR primary.
Key efficacy and clinical outcomes
Median PFS 5.6 vs 4.5 mo (HR 0.66); ORR 28.1% vs 13.2%; OS 10.6 vs 11.3 mo (HR 1.01), no OS benefit.
Source-reported outcome visualization
Values are reproduced from the cited report; bars are scaled within this figure. Previously treated KRAS G12C-mutated advanced NSCLC
Median survival and hazard ratios are not fixed-time event risks; NNT is not inferred from them.
Toxicity and treatment burden
Diarrhoea, nausea and hepatotoxicity; docetaxel causes myelosuppression/neuropathy.
Absolute effect and NNT/NNH
PFS improved; OS did not. Post-platinum/post-immunotherapy setting only.
NNT/NNH is not calculated unless a directly reported, comparable fixed-time risk difference supports it. Median survival and hazard ratios alone do not provide an NNT.
Critical interpretation and limitations
PFS improved; OS did not. Post-platinum/post-immunotherapy setting only.
This page is an evidence summary, not a substitute for multidisciplinary assessment or patient-specific decision-making.
Current-practice context
Review date: 9 November 2026. Primary publication and selected follow-up sources were reviewed. Full disease-specific guideline, regulatory-label and sequencing audit remains pending; verify current local recommendations and biomarker eligibility before clinical application.