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Active Not Recruiting NCT04875585

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

Conditions: Non Small Cell Lung Cancer

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 33
Sponsor: Medical University Innsbruck

Location: Medical University Innsbruck Innsbruck Tyrol

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.

Eligibility Criteria

Inclusion Criteria: 1. Male/female participants ≥18 years of age 2. Histologically confirmed primary diagnosis of resectable NSCLC, stages IA2-IIIA (max. single station N2). 3. Measurable disease based on RECIST 1.1. 4. Male participants must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 120 additional days after the last dose of study treatment and refrain from donating sperm during this period. 5. Female participants are eligible to participate if not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR 2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 120 days after the last dose of study treatment. 6. Written informed consent provided 7. ECOG performance status of 0 to 1 8. Adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment. Exclusion Criteria: 1. A woman with child-bearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to inclusion (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 2. Uncontrolled blood pressure (systolic BP\>160mmHg or diastolic BP \>95mmHg) despite an optimized regimen of antihypertensive medication. 3. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, and/or cardiac arrhythmia requiring medical treatment at screening. 4. History of prolonged QT syndrome, or family member with prolonged QT syndrome 5. QTc interval \>490 msec when 3 consecutive ECG values are averaged 6. Bleeding and/or thrombotic disorders and/or subjects at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following Lenvatinib therapy. 7. Subjects having \> 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04875585). StuddyBuddy aggregates publicly available trial information.