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Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer

StatusTerminated
PhasePhase 2
SponsorGenmab
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial terminated Sponsor's reason: Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns. Study completion date changed from estimate of Aug 30, 2026 to Aug 31, 2026 · Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 3 of 5 entries · 2 more Show 5 more changesShow less
    • Study completion date changed from estimate of Aug 30, 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Site details revised at 1 of 40 sites
    • Collaborators: details revised at 1 of 1 entry
  2. Completion date: May 27, 2027 to Aug 30, 2026v44
  3. Study sites: 42 to 40 Completion date: Mar 2027 to May 27, 2027v43 Show 1 more changeShow less
    • Completion date: Mar 2027 to May 27, 2027
  4. Study sites: 49 to 42v42
  5. 2 versions Re-verified since May 5, 2025, no change to tracked fieldsv40-v41
Show 38 earlier versionsHide 38 earlier versions
  1. Collaborators: 2 to 1v39 See this version in full on ClinicalTrials.gov ↗
  2. 3 versions Re-verified since Jan 6, 2025, no change to tracked fieldsv36-v38
  3. Primary completion date changed from estimate of Nov 2024 to Dec 2, 2024v35
  4. Re-verified, no change to tracked fieldsv34
  5. Study sites: 52 to 49 Study description shortened, about 48 words · Eligibility criteria shortened, about 4 wordsv33 Show 2 more changesShow less
    • Study description shortened, about 48 words
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  6. 4 versions Re-verified since Jul 1, 2024, no change to tracked fieldsv29-v32
  7. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 160 to confirmed 125 · Site details revised at 52 of 52 sitesv28 Show 2 more changesShow less
    • Enrollment target: estimated 160 to confirmed 125
    • Site details revised at 52 of 52 sites
  8. Re-verified, no change to tracked fieldsv27
  9. Primary completion date: Mar 2024 to Nov 2024 Completion date: Jun 2024 to Mar 2027 · Eligibility criteria shortened, about 17 words · Collaborators: 1 to 2v26 Show 3 more changesShow less
    • Completion date: Jun 2024 to Mar 2027
    • Eligibility criteria shortened, about 17 words
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  10. Re-verified, no change to tracked fieldsv25
  11. Interventions: GEN1046 (Biological), Pembrolizumab (Biological) to Acasunlimab (Biological), Pembrolizumab (Biological) Eligibility criteria revised · Study description expanded, about 1 wordv24 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 50 to 52v23
  13. Study sites: 45 to 50v22
  14. Study sites: 41 to 45v21
  15. Study sites: 37 to 41v20
  16. Study sites: 36 to 37v19
  17. Study sites: 34 to 36v18
  18. Study sites: 30 to 34v17
  19. Study sites: 27 to 30v16
  20. Study sites: 25 to 27v15
  21. Study sites: 21 to 25v14
  22. Study sites: 19 to 21v13
  23. Study sites: 15 to 19v12
  24. Enrollment target: 132 to 160 Primary completion date: Jan 31, 2024 to Mar 2024 · Completion date: Sep 30, 2024 to Jun 2024 · Eligibility criteria expanded, about 62 words · 2 morev11 Show 5 more changesShow less
    • Primary completion date: Jan 31, 2024 to Mar 2024
    • Completion date: Sep 30, 2024 to Jun 2024
    • Eligibility criteria expanded, about 62 words
    • Secondary endpoints revised (5)
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  25. Study sites: 12 to 15v10
  26. Study sites: 10 to 12v9
  27. Site details revised at 1 of 10 sitesv8
  28. Study sites: 9 to 10v7
  29. Study sites: 8 to 9v6
  30. Study sites: 5 to 8v5
  31. Enrollment target: 126 to 132 Study sites: 3 to 5 · Primary completion date: Dec 31, 2023 to Jan 31, 2024 · Completion date: Nov 30, 2024 to Sep 30, 2024 · 1 morev4 Show 4 more changesShow less
    • Study sites: 3 to 5
    • Primary completion date: Dec 31, 2023 to Jan 31, 2024
    • Completion date: Nov 30, 2024 to Sep 30, 2024
    • Eligibility criteria expanded, about 46 words

    See this version in full on ClinicalTrials.gov ↗

  32. Study sites: 2 to 3v3
  33. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2 · Start date changed from estimate of Oct 31, 2021 to Oct 27, 2021v2 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Oct 31, 2021 to Oct 27, 2021
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the safety and efficacy (how well the drug works) of acasunlimab (also known as GEN1046) when it is used alone (monotherapy) versus when it is combined with a cancer drug (pembrolizumab) for participants with relapsed/refractory (disease has returned after treatment or did not respond to treatment) non-small cell lung cancer (NSCLC; the most common type of lung cancer). This trial has 2 parts. The purpose of the first part is to find out if the combination of acasunlimab and pembrolizumab is safe and to find out the best doses to use. The purpose of the second part is to give acasunlimab and pembrolizumab to more participants to evaluate efficacy. In the second part of the trial, participants will be randomized to participate in 1 of the 3 arms of the trial. Randomized means that the participant will be randomly assigned to a treatment arm based on chance; no one chooses their treatment arm. Participants will receive either acasunlimab alone (100 followed by 500 mg into the vein) or acasunlimab with pembrolizumab (200 or 400 mg into the vein) once every 3 or 6 weeks, depending on which arm the participant is randomized into. All participants will receive active drug; no one will receive placebo. Trial details include: * The average trial duration for an individual participant will be about 10 months. * The average treatment duration for an individual participant will be about 6 months. * The visit frequency will be weekly at first and lessening over time until visits are only once every 3 weeks.
Trial Details
NCT Number NCT05117242
Lead Sponsor Genmab
Collaborators: Merck Sharp & Dohme LLC
Conditions Non Small Cell Lung Cancer Metastatic
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov