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This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.

StatusRecruiting
PhasePhase 3
SponsorPfizer
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial sites expanded: 372 → 389 locations
    • Eligibility criteria expanded, about 74 words
    • Secondary endpoints: 11 to 13
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 329 → 372 locationsv18
  3. Study sites: 330 to 329v17
  4. Trial sites expanded: 315 → 330 locationsv16
  5. Study sites: 296 to 315v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 241 to 296v14
  2. Study sites: 152 to 241v13
  3. Study sites: 106 to 152v12
  4. Study sites: 62 to 106v11
  5. Start date: May 4, 2025 to Jul 23, 2025
    • Study sites: 46 to 62
    v10
  6. Study sites: 22 to 46v9
  7. Re-verified, no change to tracked fieldsv8
  8. Study sites: 7 to 22v7
  9. Study sites: 3 to 7v6
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of May 31, 2025 to May 4, 2025
    • Eligibility criteria expanded, about 4 words
    v5
  11. Re-verified, no change to tracked fieldsv4
  12. Study sites: 5 to 0
    • Eligibility criteria expanded, about 8 words
    v3
  13. Start date: Jan 20, 2025 to May 31, 2025
    • Study sites: 0 to 5
    • Primary completion date: Aug 24, 2028 to Sep 5, 2028
    • Study completion date: Feb 17, 2029 to Mar 1, 2029
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of "brake" to keep the body's immune responses under control. The study is seeking for participants who: * Are confirmed to have NSCLC (Stage 3 or 4). * Have PD-L1 levels in more than 50% of the cancer cells. All participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab. Participants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee how each participant is doing with the study treatment during regular visits at the clinic.
Trial Details
NCT Number NCT06758401
Lead Sponsor Pfizer
Conditions
(from sponsor)		 Non-Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Carcinoma, Non-Small-Cell Lung (NSCLC)
Related terms Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
Enrollment 714 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov