deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03358875

Comparison of Efficacy and Safety of Tislelizumab (BGB-A317) Versus Docetaxel as Treatment in the Second- or Third-line Setting in Participants With Non-Small Cell Lung Cancer (NSCLC) (RATIONALE-303)

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

Sponsor: BeiGene

Updated 25 times since 2017 Last updated: Jan 16, 2025 Started: Nov 30, 2017 Primary completion: Jul 15, 2021 Completion: Jan 18, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Non-small Cell Lung Cancer and is currently completed. BeiGene leads this study, which shows 25 recorded versions since 2017 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Dec 2017 – ~Jul 2018 · 7 months · monthly snapshot~Jul 2018 – ~Nov 2018 · 4 months · monthly snapshot~Nov 2018 – ~Feb 2019 · 3 months · monthly snapshot~Feb 2019 – ~Aug 2019 · 6 months · monthly snapshot~Aug 2019 – ~Oct 2019 · 2 months · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~May 2020 · 5 months · monthly snapshot~May 2020 – ~Jul 2020 · 2 months · monthly snapshot~Jul 2020 – ~Sep 2020 · 2 months · monthly snapshot~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Jul 2022 · 10 months · monthly snapshot~Jul 2022 – ~Mar 2023 · 8 months · monthly snapshot~Mar 2023 – ~Sep 2023 · 6 months · monthly snapshot~Sep 2023 – ~Mar 2024 · 6 months · monthly snapshot~Mar 2024 – ~Jun 2024 · 3 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Mar 2025 · 4 months · monthly snapshot~Mar 2025 – ~Sep 2025 · 6 months · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 10 months · monthly snapshot

Change History

25 versions recorded
  1. Oct 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Oct 2025 [monthly]

    Completed PHASE3

  3. Mar 2025 — Sep 2025 [monthly]

    Completed PHASE3

  4. Nov 2024 — Mar 2025 [monthly]

    Completed PHASE3

  5. Sep 2024 — Nov 2024 [monthly]

    Completed PHASE3

Show 20 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  2. Jun 2024 — Jul 2024 [monthly]

    Completed PHASE3

  3. Mar 2024 — Jun 2024 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Sep 2023 — Mar 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Mar 2023 — Sep 2023 [monthly]

    Active Not Recruiting PHASE3

  6. Jul 2022 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  7. Sep 2021 — Jul 2022 [monthly]

    Active Not Recruiting PHASE3

  8. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  9. Jan 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  10. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  11. Jul 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE3

  12. May 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  13. Dec 2019 — May 2020 [monthly]

    Recruiting PHASE3

  14. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  15. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  16. Aug 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  17. Feb 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  18. Nov 2018 — Feb 2019 [monthly]

    Recruiting PHASE3

  19. Jul 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  20. Dec 2017 — Jul 2018 [monthly]

    Recruiting PHASE3

    First recorded

Nov 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • BeiGene
Data source: BeiGene

For direct contact, visit the study record on ClinicalTrials.gov .