Relapsed / Refractory · Phase III multicentre open-label randomized; N=453; KRAS G12C advanced NSCLC after platinum and immunotherapy. Adagrasib 600 mg BID vs docetaxel 75 mg/m² q3w. Primary endpoint BICR PFS. · Median PFS 5.5 vs 3.8 months

KRYSTAL-12

Clinical question: Does adagrasib improve PFS over docetaxel in previously treated KRAS G12C-mutated NSCLC?

Median PFS 5.5 vs 3.8 months; HR 0.58 (95% CI 0.45–0.76; P<0.0001). · Registry:

Design, population and treatment

Phase III multicentre open-label randomized; N=453; KRAS G12C advanced NSCLC after platinum and immunotherapy. Adagrasib 600 mg BID vs docetaxel 75 mg/m² q3w. Primary endpoint BICR PFS.

Key efficacy outcome

5.5 · intervention

3.8

5.5 · comparator

Not calculable from median PFS.

Grade ≥3 treatment-related AEs 47% vs 46%; treatment-related deaths 1% in each arm.

Safety and absolute effect

Median PFS (months)

https://pubmed.ncbi.nlm.nih.gov/40783289/

Interpretation and limitations

Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.

Primary source

Primary publication · DOI: 10.1016/S0140-6736(25)00866-9