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Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 2 of 5 changed
See other at-risk trials from Boehringer Ingelheim

Record History

The 50 most recent of 97 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Eligibility criteria expanded, about 170 words · Secondary endpoints revised (30) · Study sites revised (85) Show 3 more changesShow less
    • Eligibility criteria expanded, about 170 words
    • Secondary endpoints revised (30)
    • Study sites revised (85)
  2. Study sites revised (85)v96 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: 608 to 554v95
  4. 2 versions Re-verified since Jun 11, 2026, no change to tracked fieldsv93-v94
  5. Study sites revised (85)v92 See this version in full on ClinicalTrials.gov ↗
Show 44 earlier versionsHide 44 earlier versions
  1. Primary endpoints revised (5) Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 554 to confirmed 608 · Eligibility criteria expanded, about 68 words · 3 morev91 Show 6 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 554 to confirmed 608
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoints: 29 to 30
    • Study sites revised (85)
    • Study arms: 9 to 10

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites revised (85)v90 See this version in full on ClinicalTrials.gov ↗
  3. Site details revised at 2 of 85 sitesv89
  4. Site details revised at 10 of 85 sitesv88
  5. Site details revised at 3 of 85 sitesv87
  6. Study sites revised (85)v86 See this version in full on ClinicalTrials.gov ↗
  7. Site details revised at 2 of 85 sitesv85
  8. Study sites revised (85)v84 See this version in full on ClinicalTrials.gov ↗
  9. Study sites revised (85)v83 See this version in full on ClinicalTrials.gov ↗
  10. Site details revised at 2 of 85 sitesv82
  11. Site details revised at 2 of 85 sitesv81
  12. Study sites: 86 to 85v80
  13. Site details revised at 7 of 86 sitesv79
  14. Study sites: 82 to 86 Secondary endpoints: 25 to 29v78 Show 1 more changeShow less
    • Secondary endpoints: 25 to 29

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 81 to 82 Secondary endpoints reorderedv77 Show 1 more changeShow less
    • Secondary endpoints reordered
  16. Site details revised at 7 of 81 sitesv76
  17. Study sites: 80 to 81v75
  18. Primary completion date: Mar 31, 2026 to Dec 30, 2026 Primary endpoints revised (5) · Study sites: 81 to 80 · Completion date: Jan 28, 2028 to Aug 30, 2028 · 3 morev74 Show 6 more changesShow less
    • Primary endpoints revised (5)
    • Study sites: 81 to 80
    • Completion date: Jan 28, 2028 to Aug 30, 2028
    • Eligibility criteria expanded, about 43 words
    • Secondary endpoints revised (25)
    • Study arms: 8 to 9

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 77 to 81v73
  20. Study sites: 78 to 77v72
  21. Study sites: 77 to 78v71
  22. Study sites: 76 to 77 Study title expanded, about 2 wordsv70 Show 1 more changeShow less
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 83 to 76 Start date: Jun 22, 2021 to Jul 2, 2021v69 Show 1 more changeShow less
    • Start date: Jun 22, 2021 to Jul 2, 2021
  24. Study sites: 84 to 83v68
  25. Study sites: 83 to 84v67
  26. Study sites: 85 to 83v66
  27. Study sites: 84 to 85 Primary completion date: Dec 31, 2025 to Mar 31, 2026v65 Show 1 more changeShow less
    • Primary completion date: Dec 31, 2025 to Mar 31, 2026
  28. Completion date: Dec 31, 2027 to Jan 28, 2028 Site details revised at 3 of 84 sitesv64 Show 1 more changeShow less
    • Site details revised at 3 of 84 sites
  29. Site details revised at 4 of 84 sitesv63
  30. Study sites revised (84)v62 See this version in full on ClinicalTrials.gov ↗
  31. Enrollment target: 371 to 554 Eligibility criteria expanded, about 122 words · Secondary endpoints revised (25) · Study arms: 6 to 8v61 Show 3 more changesShow less
    • Eligibility criteria expanded, about 122 words
    • Secondary endpoints revised (25)
    • Study arms: 6 to 8

    See this version in full on ClinicalTrials.gov ↗

  32. Study sites: 83 to 84v60
  33. Site details revised at 1 of 83 sitesv59
  34. Study sites: 82 to 83v58
  35. Study sites: 81 to 82v57
  36. Study sites: 78 to 81 Interventions: BI 1810631 (Drug) to zongertinib (Drug)v56 Show 1 more changeShow less
    • Interventions: BI 1810631 (Drug) to zongertinib (Drug)
  37. Study sites: 77 to 78v55
  38. Study sites: 76 to 77v54
  39. Study sites: 74 to 76v53
  40. Study sites: 71 to 74v52
  41. Study sites: 68 to 71v51
  42. Study sites: 65 to 68v50
  43. Study sites: 61 to 65 Completion date: Dec 31, 2025 to Dec 31, 2027v49 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Dec 31, 2027
  44. Study sites: 60 to 61v48
  • 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 study has 2 parts. The first part is open to adults with different types of advanced cancer (solid tumours with changes in the HER2 gene) for whom previous treatment was not successful. The second part is open to people with non-small cell lung cancer with a specific mutation in the HER2 gene. The purpose of the first study part is to find the highest dose of a medicine called zongertinib the participants can tolerate. Once this dose is found, it will be used in the second study part to test whether zongertinib can make tumours shrink. In this study, zongertinib is given to people for the first time. Participants take zongertinib as tablets once a day or twice a day. The participants are in the study for as long as they benefit from and can tolerate treatment. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by zongertinib.
Trial Details
NCT Number NCT04886804
Lead Sponsor Boehringer Ingelheim
Conditions Neoplasm Metastasis, Non-Small Cell Lung Cancer
Enrollment 554 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov