Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Study acronym: LIVIGNO-4
StatusActive, Not Recruiting
PhasePhase 2/3
SponsorAbbVie
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 67 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 2 entries Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Final enrollment: 167 participants (planned 840)
    • Secondary endpoints: details revised at 8 of 12 entries
    • Study sites revised (61)
    • Eligibility criteria expanded, about 3 words
  2. Site details revised at 1 of 61 sitesv66
  3. Site details revised at 1 of 61 sitesv65
  4. Site details revised at 1 of 61 sitesv64
  5. Site details revised at 1 of 61 sitesv63
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 61 sitesv62
  2. Study sites revised (61)v61
  3. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 167 to 840
    • Site details revised at 61 of 61 sites
    v60
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 840 to confirmed 167
    • Study sites revised (61)
    v59
  5. Study sites: 59 to 61v58
  6. Study sites: 58 to 59v57
  7. Study sites revised (58)v56
  8. Study sites: 56 to 58v55
  9. Re-verified, no change to tracked fieldsv54
  10. Study sites: 55 to 56v53
  11. Study sites: 54 to 55v52
  12. Study sites: 52 to 54v51
  13. Study sites: 50 to 52v50
  14. Study sites: 49 to 50v49
  15. Study sites: 48 to 49v48
  16. Study sites: 46 to 48v47
  17. Study sites: 44 to 46v46
  18. Site details revised at 1 of 44 sitesv45
  19. Study sites: 43 to 44v44
  20. Study sites: 42 to 43v43
  21. Study sites: 39 to 42v42
  22. Study sites: 38 to 39v41
  23. Study sites: 36 to 38v40
  24. Study sites: 34 to 36v39
  25. Study sites: 33 to 34v38
  26. Study sites: 32 to 33v37
  27. Re-verified, no change to tracked fieldsv36
  28. Study sites: 31 to 32v35
  29. Site details revised at 1 of 31 sitesv34
  30. Study sites: 30 to 31v33
  31. Study sites: 29 to 30v32
  32. Re-verified, no change to tracked fieldsv31
  33. Study sites: 28 to 29v30
  34. Primary and study completion dates: Oct 8, 2031 to Oct 2031v29
  35. Study sites: 27 to 28v28
  36. Study sites: 26 to 27v27
  37. Study sites: 24 to 26v26
  38. Study sites: 23 to 24v25
  39. Re-verified, no change to tracked fieldsv24
  40. Site details revised at 1 of 23 sitesv23
  41. Study sites: 19 to 23v22
  42. Study sites: 16 to 19v21
  43. Re-verified, no change to tracked fieldsv20
  44. Study sites: 15 to 16v19
  45. Study sites: 14 to 15v18
  • 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.
Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer. Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide. Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will receive livmoniplimab (dose B) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In cohort 3, participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed . In cohort 4, participants will receive IV Infused pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. Stage 2: In arm 1, participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Trial Details
NCT Number NCT06236438
Lead Sponsor AbbVie
Conditions
(from sponsor)		 Non-Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 167 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov