Phase II Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib and Adjuvant Pembrolizumab in Patients With Surgically Resectable Non-Small- Cell Lung Cancer (NSCLC)
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.
• Male/female participants ≥18 years of age
• Histologically confirmed primary diagnosis of resectable NSCLC, stages IA3-IIIA (max. single station N2).
• Measurable disease based on RECIST 1.1.
• 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:
‣ Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
⁃ 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.