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Terminated PHASE2 INTERVENTIONAL 2-arm NCT04396535

Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer

Randomized Phase II Study of Standard Chemotherapy With Docetaxel With or Without Bintrafusp Alfa in Patients With Advanced NSCLC After Progressing on a Combination of Anti-PD-1/PD-L1 Agents and Chemotherapy

Sponsor: Mayo Clinic

Conditions Advanced Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8
Interventions Bintrafusp Alfa Docetaxel
Updated 14 times since 2020 Last updated: Nov 3, 2025 Started: Oct 23, 2020 Primary completion: Dec 31, 2023 Completion: Dec 31, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

EMD Serono recommendation based on three other studies that failed to show benefit for bintrafusp alfa

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Listed as NCT04396535, this PHASE2 trial focuses on Advanced Lung Non-Small Cell Carcinoma and Stage III Lung Cancer AJCC v8 and remains terminated or withdrawn. Sponsored by Mayo Clinic, it has been updated 14 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jun 2020 – ~Sep 2020 · 3 months · monthly snapshot~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Jun 2021 · 5 months · monthly snapshot~Jun 2021 – ~Nov 2021 · 5 months · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Aug 2023 · 6 months · monthly snapshot~Aug 2023 – ~Feb 2024 · 6 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2025 · 15 months · monthly snapshot~Dec 2025 – present · 9 months · monthly snapshot

Change History

14 versions recorded

  1. Dec 2025 — Present [monthly]

    Terminated PHASE2

  2. Sep 2024 — Dec 2025 [monthly]

    Terminated PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  4. Feb 2024 — Jul 2024 [monthly]

    Terminated PHASE2

    Status: Active Not Recruiting → Terminated

  5. Aug 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE2

▶ Show 9 earlier versions

  1. Feb 2023 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2

  2. Dec 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE2

  3. Dec 2021 — Dec 2022 [monthly]

    Active Not Recruiting PHASE2

  4. Nov 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  5. Jun 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

  6. Jan 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  7. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  8. Sep 2020 — Nov 2020 [monthly]

    Not Yet Recruiting PHASE2

  9. Jun 2020 — Sep 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mayo Clinic
Data source: Mayo Clinic

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

Study Locations