ArticleJTO clinical and research reports2026
RATIONALE-303: Long-Term Outcomes of Tislelizumab in Previously Treated Advanced/Metastatic NSCLC.
Article in JTO clinical and research reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03358875 (A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of BGB-A317 (Anti-PD1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer Who Have Progressed on a Prior Platinum-Containing Regimen
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: RATIONALE-303 (NCT03358875) investigated the efficacy and safety of tislelizumab versus docetaxel in pretreated patients with advanced NSCLC. We present long-term outcomes with an additional 30-month follow-up after the final analysis. Methods: In this open-label, randomized, phase 3 trial, patients aged 18 years or older with locally advanced or metastatic NSCLC that progressed on prior platinum-based chemotherapy were randomized (2:1) to tislelizumab or docetaxel. The dual primary end points were overall survival (OS) in the intent-to-treat (ITT) population and OS in patients with programmed death-ligand 1 (PD-L1) tumor cell expression 25% or greater. Secondary end points included progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), and safety. Results: A total of 805 patients were randomized (ITT: tislelizumab, Conclusions: Extended follow-up confirmed clinically meaningful improvements in OS and other efficacy outcomes with tislelizumab versus docetaxel in previously treated advanced/metastatic NSCLC, with a favorable safety profile. Clinical trial registration: NCT03358875.
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