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Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC

Study acronym: INNWOP1
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 24, 2022 (before its estimated December 2023 completion). Its status may not reflect the trial's current state.

Record History

  1. Start date changed from estimate of Sep 2021 to May 12, 2021
    • Site contact updated
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 2021 to Sep 2021
    • Study sites: 0 to 1
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 primary aim of this single arm, phase II study is to determine the efficacy of the combination therapy Pembrolizumab/Lenvatinib regarding the rate of major pathological response (MPR-Rate). The investigators expect to improve the MPR-Rate of 20% in Anti-PD1/-PD-L1 monotherapy (observed in recent trials) to a MPR-Rate of 40% with the combination therapy Pembrolizumab/Lenvatinib.
Trial Details
NCT Number NCT04875585
Lead Sponsor Medical University Innsbruck
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Non Small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov