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AMAZE-lungNCT05601973

Amivantamab, Lazertinib and Bevacizumab in Patients With EGFR-mutant Advanced Non-small Cell Lung Cancer With Progression on Previous Third-generation EGFR-TKI

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
Track this trial

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Record History

All 21 versions: 20 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 39 words
    • Study completion pushed from Sep 30, 2026 to Apr 2027
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 1 of 18 sites
  2. Primary completion date changed from estimate of Mar 30, 2026 to Aug 24, 2024v20
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 20 to 18
    v19
  4. Study sites revised (20)
    • Study title shortened, about 1 word
    v18
  5. Study sites: 21 to 20v17
Show 14 earlier versionsHide 14 earlier versions
  1. Site details revised at 1 of 21 sitesv16
  2. Study sites: 28 to 21v15
  3. Study sites: 29 to 28v14
  4. Study sites: 32 to 29v13
  5. Site details revised at 1 of 32 sitesv12
  6. Site details revised at 2 of 32 sitesv11
  7. Site details revised at 1 of 32 sitesv10
  8. Study sites: 31 to 32v9
  9. Site details revised at 2 of 31 sitesv7
  10. Site details revised at 1 of 31 sitesv6
  11. Site details revised at 1 of 31 sitesv5
  12. Site details revised at 2 of 31 sitesv4
  13. Start date: Mar 14, 2023 to Mar 27, 2023v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 1, 2023 to Mar 14, 2023
    • Site details revised at 31 of 31 sites
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Efficacy of amivantamab and bevacizumab added to continued treatment with a third-generation EGFR-TKI (osimertinib or lazertinib)
Timeframe: from date of enrolment until 12 weeks of follow-up.

Secondary (3)

To evaluate secondary measures of clinical efficacy including progression-free survival (PFS), overall survival (OS), duration of response (DoR), disease control rate (DCR).
To evaluate secondary measures of clinical efficacy including progression-free survival
Safety and tolerability of the treatment based on any reported adverse events (any-cause, treatment-related, AEs leading to dose interruptions, withdrawal of treatment, and death as well as severe, serious and selected adverse events) and deaths

Arms and interventions

Treatment ArmExperimental

Amivantamab (fixed dose of 1750 mg (or 2100 mg, i.v. every 3 weeks, until disease progression, or intolerable toxicity) PLUS Lazertinib (240 mg, orally, once daily, until disease progression or intolerable toxicities) PLUS Bevacizumab (Zirabev® is administered at a dose of 15mg/kg, i.v. every 3 weeks, until disease progression, or intolerable toxicity).

Drugs: Amivantamab, Lazertinib, Zirabev

Sites

18 sites in 6 countries

Spain 8, Switzerland 4, France 3, Italy 1, Netherlands 1, United Kingdom 1