RATIONALE-315
Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
- NCT04379635 ↗
- Active, not recruiting
- BeiGene
- Deep
We haven't built an HCP commentary report on RATIONALE-315 (tislelizumab in resectable stage II–IIIA non-small cell lung cancer) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Questions raised in the commentary
Automated from the 37 newest of 39 indexed sources (Oct 2023 – Oct 2026). Each question is raised in at least two. Not an Erudio report: no source links. Not medical advice.
- Whether adjuvant immunotherapy adds value, and which patients can forgo it
- How biomarkers, including PD-L1, can guide treatment selection
- How MRD or ctDNA could guide treatment decisions
- How pathological response should be assessed and interpreted
Also discussed: cross-trial comparisons.
Indexed commentary on RATIONALE-315 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 33 | |
| YouTube | 3 | |
| Podcasts | 3 |
The trial
ClinicalTrials.gov- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer
- Phase
- Phase 3
- Status
- Active, not recruiting
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Tislelizumab; Cisplatin injection; Paclitaxel injection; Pemetrexed Disodium; Placebos; Carboplatin
- Arms
- Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab · Experimental
- Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo · Placebo comparator
- Enrollment
- 453
- Primary outcomes
- Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set
- Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR)
- Sponsor
- BeiGene
- Start
- May 29, 2020
- Primary completion
- Aug 21, 2023
- Results posted
- No
- Registry record
- NCT04379635 · updated Mar 18, 2026
Publications
linked from the registry- Wang C, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Zhang Z, Yao B, Wang S, Leaw S, Naicker K, Zheng W, Yu C, Yue D; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer: final analysis of the randomized RATIONALE-315 trial. Ann Oncol. 2026 Apr;37(4):544-554. doi: 10.1016/j.annonc.2025.11.017. Epub 2025 Dec 2. PubMed 41344593
- Yue D, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Cheng Y, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Yao B, Wang S, Wang RH, Zheng W, Wang C; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial. Lancet Respir Med. 2025 Feb;13(2):119-129. doi: 10.1016/S2213-2600(24)00269-8. Epub 2024 Nov 21. PubMed 39581197