# Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

Source: https://onco.cc/trials/nct04379635/  
OnCo record `nct04379635` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Tislelizumab, Cisplatin, Paclitaxel / nab-paclitaxel in non-small-cell lung cancer and small-cell lung cancer, run by BeiGene, active and no longer recruiting.

## Summary

Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT04379635 by BeiGene, with 453 participants enrolled, started 2020-05-29 and due to reach its primary completion in 2023-08-21. Interventions recorded: Tislelizumab, Cisplatin injection, Paclitaxel injection, Pemetrexed Disodium, Placebos. Conditions listed: Non Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Also known as: RATIONALE-315
- Tags: ctgov-ingest
- Registry id: NCT04379635
- Phase: 3
- Setting: 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
- Sponsor: BeiGene
- Enrolled: 453
- Result: At the final analysis (median follow-up 38.5 months) overall survival favoured perioperative tislelizumab (hazard ratio 0.65, 95 percent confidence interval 0.45 to 0.93, p=0.009); 36-month overall survival 79.3 against 69.3 percent.

## Notes

- RATIONALE-315 randomised 453 adults in China with resectable stage II to IIIA non-small-cell lung cancer 1:1 to perioperative tislelizumab (226) or placebo (227) with neoadjuvant chemotherapy, with dual primary endpoints of event-free survival and major pathological response by blinded independent central review. Median overall survival was not reached in either group. It is one of the four perioperative chemoimmunotherapy trials that, with AEGEAN, CheckMate 77T and Neotorch, established the schedule (Annals of Oncology 2026).

## Sources

- ClinicalTrials.gov NCT04379635: https://clinicaltrials.gov/study/NCT04379635
- RATIONALE-315 final analysis (Annals of Oncology 2026): https://doi.org/10.1016/j.annonc.2025.11.017

## Connected records

- cancers: [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Resectable stage I to III non-small-cell lung cancer](https://onco.cc/cancers/resectable-nsclc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/), [Cisplatin](https://onco.cc/drugs/cisplatin/), [Paclitaxel / nab-paclitaxel](https://onco.cc/drugs/paclitaxel/), [Pemetrexed](https://onco.cc/drugs/pemetrexed/), [Tislelizumab](https://onco.cc/drugs/tislelizumab/)
- companies: [BeOne Medicines (formerly BeiGene)](https://onco.cc/companies/beone/)
- trials: [A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer](https://onco.cc/trials/nct04025879/), [A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer](https://onco.cc/trials/nct03800134/), [KEYNOTE-671](https://onco.cc/trials/keynote-671/), [Neotorch](https://onco.cc/trials/neotorch/)
- key papers: [Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial](https://onco.cc/key-papers/paper-nct04379635-lancet-respir-med-2025/), [Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer: final analysis of the randomized RATIONALE-315 trial](https://onco.cc/key-papers/paper-nct04379635-ann-oncol-2026-update/)

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