Consolidation · Phase III multicentre double-blind randomized trial; N=553 unresectable stage III NSCLC after CRT. Benmelstobart+anlotinib, benmelstobart alone or placebo. Primary endpoint IRC PFS. · Stage 1 median PFS 15.1, 9.7 and 4.2 months, respectively

R-ALPS

Clinical question: After chemoradiotherapy for unresectable stage III NSCLC, does benmelstobart with or without anlotinib improve PFS over placebo?

Stage 1 median PFS 15.1, 9.7 and 4.2 months, respectively; HR vs placebo 0.49 and 0.53. Pooled combo vs benmelstobart alone 17.4 vs 11.2 months; HR 0.82 (95% CI 0.63–1.08; P=0.12), not significant. · Registry:

Design, population and treatment

Phase III multicentre double-blind randomized trial; N=553 unresectable stage III NSCLC after CRT. Benmelstobart+anlotinib, benmelstobart alone or placebo. Primary endpoint IRC PFS.

Key efficacy outcome

15.1 · intervention

4.2

15.1 · comparator

No NNT from medians. Adding anlotinib did not significantly improve PFS over benmelstobart alone and increased severe/fatal toxicity.

Grade 3–5 treatment-related AEs 48.8%, 29.4%, 19.7%; grade 5 events 7.2%, 1.4%, 1.5%.

Safety and absolute effect

Stage 1 median PFS (months)

https://pubmed.ncbi.nlm.nih.gov/42955021/

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: 10.1001/jamaoncol.2026.3918