The Absolute Effect / Evidence index

Adjuvant / Postoperative · Phase III randomized; 166 enrolled, 153 centrally ALK-positive resected NSCLC. Crizotinib 250 mg BID up to 2 years vs observation. Primary endpoint DFS. · Median DFS 74.6 vs 75.1 months

ECOG-ACRIN E4512 / ALCHEMIST-ALK

Clinical question: Does adjuvant crizotinib improve DFS over observation after resection of ALK-positive NSCLC?

Median DFS 74.6 vs 75.1 months; HR 1.08 (95% CI 0.61–1.90; P=0.80). Adjuvant crizotinib did not prolong DFS. · Registry:

Design, population and treatment

Phase III randomized; 166 enrolled, 153 centrally ALK-positive resected NSCLC. Crizotinib 250 mg BID up to 2 years vs observation. Primary endpoint DFS.

Key efficacy outcome

74.6 · intervention
75.1
74.6 · comparator
No NNT: negative efficacy result.

Grade ≥3 AEs of any attribution in 58% receiving crizotinib; common diarrhoea, oedema, hypertension.

Safety and absolute effect

Median DFS (months)

https://pmc.ncbi.nlm.nih.gov/articles/PMC13637573/

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/S2213-2600(26)00192-X