Phase II trial exploring combined neoadjuvant therapy with Pembrolizumab/Lenvatinib and adjuvant Pembrolizumab in patients with surgically resectable Non-Small- Cell Lung Cancer (NSCLC)

Medizinische Universitaet Innsbruck1 site in 1 country33 target enrollmentSeptember 8, 2024

DrugsBAT3306 FYB206 Lenvatinib, Lenvatinib Pabolizumab SCH-900475 KEYTRUDA 25 mg/mL concentrate for solution for infusion Lenvatinib ABP 234 Lambrolizumab MK-3475

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Medizinische Universitaet Innsbruck
Enrollment: 33
Locations: 1
Primary Endpoint: Achievment of major pathological response after neoadjuvant immunotherapy in combination with angiogenesis inhibition
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The rate of major pathological response (MPR) upon neoadjuvant combination therapy with Pembrolizumab and Lenvatinib.

Registry

euclinicaltrials.eu

Start Date

September 8, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Medizinische Universitaet Innsbruck

Responsible Party

Principal Investigator

University Hospital for Internal Medicine V

Scientific

Medizinische Universitaet Innsbruck

Eligibility Criteria

Inclusion Criteria

•Male/female participants ≥18 years of age
•Histologically or cytologically confirmed primary diagnosis of resectable NSCLC, stages IA2 (minimum primary-tumor diameter 1,5cm) - IIIA (max. single station N2).
•Measurable disease based on RECIST 1.
•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.
•Female participants are eligible to participate if not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies: a.) Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b.) 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.
•Written informed consent provided
•ECOG performance status of 0 to 1
•Adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment.

Exclusion Criteria

•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.
•Patient has received prior radiotherapy for the newly diagnosed NSCLC.
•Patient has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
•Patient is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
•Diagnosis of immunodeficiency and/or patient is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
•Known additional malignancy that is progressing.
•Known history of severe (≥Grade 3) allergic or hypersensitivity reactions to Pembrolizumab or Lenvatinib and/or any of their excipients.
•Known active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
•History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
•Active infection requiring systemic therapy.