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Bending the Curve Trial by Trial
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CodeBreaK 200

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

Phase 3N = 345NCT04303780

Population
KRAS G12C-mutated advanced NSCLC that progressed after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor
Design
Randomised (1:1), open-label phase 3 trial at 148 centres in 22 countries: sotorasib 960 mg orally once daily versus docetaxel 75 mg/m2 intravenously every 3 weeks, in KRAS G12C-mutated advanced NSCLC progressing after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor. Primary endpoint progression-free survival by blinded independent central review.
Primary endpoint
PFS
Arms
  • Docetaxel (control, n = 174): Docetaxel 75 mg/m2 intravenously every 3 weeks
  • Sotorasib (experimental, n = 171): Sotorasib 960 mg orally once daily
People
de Langen AJ
PFSHR 0.66 (95% CI 0.51–0.86)Δ median PFS+1.1 months
Show the numbers
Results reported for CodeBreaK 200
EndpointAnalysisSotorasibDocetaxelEffect
PFSPFS assessed by blinded independent central reviewprimarymedian follow-up 17.7 monthsde 2023median 5.6 months (4.3–7.8)median 4.5 months (3.0–5.7)HR 0.66 (95% CI 0.51–0.86)P=0.0017
Results reported for CodeBreaK 200
EndpointAnalysisSotorasibDocetaxelEffect
PFSPFS assessed by blinded independent central reviewprimarymedian follow-up 17.7 monthsde 2023median 5.6 months (4.3–7.8)median 4.5 months (3.0–5.7)HR 0.66 (95% CI 0.51–0.86)P=0.0017
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.660.51–0.86
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Docetaxel (control)
  • Sotorasib (experimental)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsDocetaxelSotorasib
0100.0%100.0%
454.0%61.0%
734.0%42.0%
1118.4%25.6%
1411.6%17.7%
Primary publication: de Langen AJ, Johnson ML, Mazieres J, Dingemans AC, Mountzios G, Pless M, et al. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRAS(G12C) mutation: a randomised, open-label, phase 3 trial. Lancet. 2023;401(10378):733-746. PubMedDOI

Appears in

Sources

  1. de Langen AJ, Johnson ML, Mazieres J, Dingemans AC, Mountzios G, Pless M, et al. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRAS(G12C) mutation: a randomised, open-label, phase 3 trial. Lancet. 2023;401(10378):733-746.

    PubMedDOI