Clinical Trial

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

Study acronym: INNWOP1
Recruiting Phase 2
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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.
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-05-03; most recent amendment 2022-08-23.
Status change: Not Yet Recruiting → Recruiting 2021-09-06
Trial Details
NCT Number NCT04875585
Lead Sponsor Medical University Innsbruck
Collaborators: Merck Sharp & Dohme LLC
Conditions Non Small Cell Lung Cancer
Enrollment 33 participants
Start Date 2021-05-12
Primary Completion 2023-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2022-08-24