# Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer: final analysis of the randomized RATIONALE-315 trial

Source: https://onco.cc/key-papers/paper-nct04379635-ann-oncol-2026-update/  
OnCo record `paper-nct04379635-ann-oncol-2026-update` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Later report from the trial registered as NCT04379635, in Annals of Oncology (2026); its title describes an updated or longer-term analysis.

## Summary

Background: Perioperative immunotherapy, particularly anti-programmed cell death protein 1 therapy, combined with neoadjuvant chemotherapy has emerged as one of the standard-of-care options for resectable non-small-cell lung cancer (NSCLC). We report the final analysis of RATIONALE-315, a randomized, double-blind, phase III trial evaluating the efficacy and safety of perioperative tislelizumab plus neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in patients with resectable, stage II-IIIA NSCLC.

Patients and methods: Adult patients in China were randomized (1: 1) to receive either perioperative tislelizumab or placebo in combination with neoadjuvant chemotherapy. The dual primary endpoints were event-free survival (EFS) and major pathological response, assessed by blinded independent central review. The secondary endpoints included pathological complete response, overall survival (OS), disease-free survival, and safety.

Results: In total, 453 patients were randomized (226 to tislelizumab and 227 to placebo). At the final analysis (median study follow-up of 38.5 months), patients in the tislelizumab group experienced statistically significantly improved OS versus those in the placebo group {hazard ratio (HR) 0.65 [95% confidence interval (CI) 0.45-0.93]; P = 0.009}. The median OS was not reached in either group. The 36-month OS rate was 79.3% in the tislelizumab group versus 69.3% in the placebo group. The median EFS was not reached in the tislelizumab group versus 30.6 months in the placebo group [HR 0.58 (95% CI 0.43-0.79)]. Survival benefits were generally consistent across subgroups. The safety profile of tislelizumab plus chemotherapy was tolerable and consistent with known profiles of the individual therapies.

Conclusions: Neoadjuvant tislelizumab plus chemotherapy and adjuvant tislelizumab demonstrated a statistically significant, clinically meaningful OS benefit and sustained, clinically meaningful EFS improvement compared with neoadjuvant chemotherapy, with a tolerable safety profile in patients with resectable stage II-IIIA NSCLC. These results support the use of this regimen in this patient population.

Clinical trial number: NCT04379635.

Indexed on Europe PMC as PubMed record 41344593 (DOI 10.1016/j.annonc.2025.11.017). Its abstract cites the registry id NCT04379635, which is how it was matched to this trial; no figure has been checked by an editor.

## Fields

- Kind: Key paper
- Last checked: 2026-09-22
- Tags: europepmc-ingest
- Journal: Annals of Oncology
- Year: 2026
- DOI: 10.1016/j.annonc.2025.11.017
- Authors: Wang C, Wang W, Liu H, et al.
- What it means: A second publication from the trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
- Caveats: Matched to the trial by the registry id cited in the Europe PMC record; the summary reproduces the record's abstract and no figure has been verified against the full paper.; Chosen as a later report by words in its title (updated, long-term, final, overall survival or a year count), not by reading the paper.

## Sources

- Ann Oncol 2026: https://doi.org/10.1016/j.annonc.2025.11.017
- PubMed: https://pubmed.ncbi.nlm.nih.gov/41344593/
- Europe PMC: https://europepmc.org/article/MED/41344593
- ClinicalTrials.gov NCT04379635: https://clinicaltrials.gov/study/NCT04379635

## Connected records

- trials: [Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct04379635/)
- journals: [Annals of Oncology](https://onco.cc/journals/annals-of-oncology/)

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