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Trial result
Non-small cell lung cancer

Platinum Doublet Lifts 2-Year DFS to 96% in Gene-High Stage I–IIA NSCLC

Trial ID
NCT01817192 on ClinicalTrials.gov
Cancer type
NSCLC
Published in
New in Oncology - July 11, 2025

Platinum-based adjuvant chemotherapy—mainly cisplatin or carboplatin doublets—was tested in the Phase 3 AIM-HIGH trial (NCT01817192), which randomized 200 resected stage IA-IIA non-squamous NSCLC patients flagged as high/intermediate risk by a CLIA-certified 14-gene expression assay to four cycles of chemo (n = 87) or observation (n = 107). At the prespecified interim read-out, 24-month disease-free survival was 96% versus 79% (HR 0.22, p = 0.0087); only six deaths occurred overall, and full grade 3+ toxicity data await maturation, though historical platinum doublets cause ≥G3 neutropenia in roughly 20-30%. The observation arm’s DFS aligns with prior surgery-alone cohorts (~75-85%), making the 17-point absolute gain markedly larger than the ~5-point 5-year benefit seen in earlier LACE meta-analysis of unselected adjuvant cisplatin.

Take home

If certified past this interim, gene-guided chemo could bring adjuvant benefit to early-stage patients previously left to watch-and-wait, redefining stage I treatment paradigms.

Source: Read the original publication

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