RATIONALE 303: A randomized phase 3 trial in nearly 805 patients with 2L, locally advanced or metastatic NSCLC (Squamous or Non-squamous)
RATIONALE-303 was a randomised, open-label, multi-centre Phase 3 study investigating the efficacy and safety of etapidi vs docetaxel in patients with locally advanced or metastatic NSCLC (squamous or non-squamous), who had experienced disease progression on or after a prior platinum based regimen.2
Stratification factors
- Squamous vs non-squamous
- 2nd vs 3rd line of therapy
- PD-L1 status (<25% vs ≥25%
TC staining)
Efficacy endpoints
- Co-primary Endpoints: OS in ITT and PD-L1 ≥25% populations
- Key Secondary Endpoints: ORR, DoR, PFS, HRQoL, safety
References: 1. TEVIMBRA. Prescribing Information. BeOne Medicines USA, Inc.; 2025. 2. Shen L, Kato K, Kim S-B, et al; RATIONALE-302 Investigators. J Clin Oncol. 2022;40(26):3065-3076. doi:10.1200/JCO.21.01926