The Absolute Effect / Evidence index

Advanced / Metastatic · Phase III open-label randomized; N=455; first-line PD-L1 TPS <1% nonsquamous NSCLC without targetable alterations. Sacituzumab tirumotecan + pembrolizumab vs platinum-pemetrexed + pembrolizumab. Primary endpoint BICR PFS. · Median PFS 15.0 vs 5.7 months

OptiTROP-Lung06

Clinical question: Does sacituzumab tirumotecan plus pembrolizumab improve PFS over platinum-pemetrexed plus pembrolizumab in first-line PD-L1-negative advanced nonsquamous NSCLC?

Median PFS 15.0 vs 5.7 months; HR 0.49 (95% CI 0.36–0.65; P<0.001). ORR 50.2% vs 47.3%; OS immature (HR 0.58). · Registry:

Design, population and treatment

Phase III open-label randomized; N=455; first-line PD-L1 TPS <1% nonsquamous NSCLC without targetable alterations. Sacituzumab tirumotecan + pembrolizumab vs platinum-pemetrexed + pembrolizumab. Primary endpoint BICR PFS.

Key efficacy outcome

15 · intervention
5.7
15 · comparator
Not calculable from median PFS.

Grade ≥3 AEs 47.6% vs 60.6%; stomatitis with sacituzumab tirumotecan predominantly grade 1–2.

Safety and absolute effect

Median PFS (months)

https://www.nejm.org/doi/full/10.1056/NEJMoa2611280

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: 10.1056/NEJMoa2611280