deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02383966

Phase III Trial to Assess Efficacy and Safety of Cetuximab for the Treatment of Chinese Participants With Head and Neck Cancer (CHANGE2)

A Multicenter, Randomized, Open-label, Phase III Trial to Assess Efficacy and Safety of Cetuximab When Given in Combination With Cisplatin Plus 5 Fluorouracil Versus Cisplatin Plus 5-fluorouracil Alone for the First-line Treatment of Chinese Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Sponsor: Merck KGaA, Darmstadt, Germany

Conditions Carcinoma, Squamous Cell of Head and Neck
Interventions 5-fluorouracil Cetuximab Cisplatin/Carboplatin
Updated 16 times since 2017 Last updated: Apr 19, 2022 Started: Jul 31, 2015 Primary completion: Jan 19, 2018 Completion: Dec 20, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Carcinoma, Squamous Cell of Head and Neck, this trial is completed. The trial is conducted by Merck KGaA, Darmstadt, Germany and has accumulated 16 data snapshots since 2015. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jun 2017 · 4 months · monthly snapshot~Jun 2017 – ~Jan 2018 · 7 months · monthly snapshot~Jan 2018 – ~Mar 2018 · 59 days · monthly snapshot~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Jan 2019 · 6 months · monthly snapshot~Jan 2019 – ~May 2019 · 4 months · monthly snapshot~May 2019 – ~Aug 2020 · 15 months · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Jun 2022 · 14 months · monthly snapshot~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jun 2022 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Apr 2021 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE3

▶ Show 11 earlier versions

  1. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  2. Aug 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  3. May 2019 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

  4. Jan 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  5. Jul 2018 — Jan 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE3

  7. Mar 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  8. Jan 2018 — Mar 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  9. Jun 2017 — Jan 2018 [monthly]

    Recruiting PHASE3

  10. Feb 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  11. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Jul 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck KGaA, Darmstadt, Germany
Data source: Merck KGaA, Darmstadt, Germany

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

Study Locations