A Study to Evaluate Adverse Events and Change in Disease Activity of Intravenous ABBV-706 Versus Standard of Care in Adult Participants With Relapsed/Refractory Small Cell Lung Cancer

StatusRecruiting
PhasePhase 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

See every version on ClinicalTrials.gov ↗

  1. Minor Trial sites expanded: 65 → 71 locations
  2. Minor Study sites: 63 to 65
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 5 entries
  3. Minor Study sites: 62 to 63v16
  4. Minor Study sites: 61 to 62v15
  5. Minor Study sites: 60 to 61v14
  6. Minor Study sites: 59 to 60v13
  7. Minor Trial sites expanded: 52 → 56 locations
    • Trial sites expanded: 49 → 52 locations
    v12
  8. Minor Study sites: 56 to 58v11
  9. Minor Study sites: 52 to 56v10
  10. Minor Study sites: 49 to 52v9
  11. Minor Study sites: 48 to 49v8
  12. Minor Study sites: 46 to 48v7
  13. Minor Study sites: 45 to 46v6
  14. Notable Recruitment opened
    • Trial sites expanded: 40 → 43 locations
    • Trial sites expanded: 0 → 40 locations
    v5
  15. Minor Study sites: 43 to 44v4
  16. Minor Study sites: 40 to 43v3
  17. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 40
    • Start date changed from estimate of Apr 14, 2026 to Jul 2, 2026
    v2
  18. Minor Study First Submitted
  • 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.
349 trials monitored
See 27 trials at risk
4,798 trials monitored
See 270 trials at risk
Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, tolerability, and change in disease activity of ABBV-706 compared to standard of care (SOC) treatment (topotecan, lurbinectedin, or amrubicin). ABBV-706 is an investigational drug being developed for the treatment of SCLC. There are two treatment arms in this study. Participants will either receive ABBV-706 or SOC. Approximately 531 adult participants will be enrolled in the study across 175 sites worldwide. Participants with SCLC will receive intravenous (IV) ABBV-706 or SOC \[topotecan (IV or orally), or lubinectedin (IV), or amrubicin (IV)\]. The estimated duration of the study is approximately 53 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 NCT07365241
Lead Sponsor AbbVie
Conditions
(from sponsor)
Small Cell Lung Cancer
Related terms Neoplasms, Small Cell Lung Carcinoma
Enrollment 531 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov