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
More in non-small cell lung cancer
-
Trial result · Oct 22, 2026 · NCT04905316
Canakinumab (IL-1β blockade) + cCRT and durvalumab consolidation hits 67% 24-mo PFS in unresectable stage III NSCLC -
Trial result · Oct 15, 2026 · NCT04495153
CAN-2409 + valacyclovir reports 14.3-month median OS in treated NSCLC patients; 24.5 months in a selected per-protocol group -
New trial · Oct 15, 2026 · NCT07852247
Phase 1 CyberKnife SBRT uses Synchrony respiratory motion tracking for ultra-central NSCLC -
New trial · Oct 15, 2026 · NCT07617337
Phase 1 AQUA07 allosteric ALK inhibitor (macrocyclic peptide) alone or with lorlatinib in ALK-positive NSCLC -
Trial result · Oct 8, 2026 · NCT03052608
AI volumetric brain-met response may better predict PFS in ALK+ NSCLC
