OncoMatch/Clinical Trials/NCT04875585
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Is NCT04875585 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including neoadjuvant therapy with Pembrolizumab/Lenvatinib and Adjuvant Treatment Phase for non small cell lung cancer.
Treatment: neoadjuvant therapy with Pembrolizumab/Lenvatinib · Adjuvant Treatment Phase — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Small Cell Lung Cancer
Disease stage
Required: Stage IA3, IB, IIA, IIB, IIIA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX 40, CD137)
Cannot have received: systemic anti-cancer therapy
prior systemic anti-cancer therapy for the newly diagnosed NSCLC including investigational agents
Cannot have received: radiation therapy
prior radiotherapy for the newly diagnosed NSCLC
Cannot have received: surgery
prior surgery therapy for the newly diagnosed NSCLC
Lab requirements
Blood counts
Adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment.
Kidney function
Adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment.
Liver function
Adequate organ function. Specimens must be collected within 14 days prior to the start of study treatment.
Cardiac function
Significant cardiovascular impairment: history of congestive heart failure greater than 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. History of prolonged QT syndrome, or family member with prolonged QT syndrome. QTc interval >490 msec when 3 consecutive ECG values are averaged.
Adequate organ function. Significant cardiovascular impairment: history of congestive heart failure greater than 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. History of prolonged QT syndrome, or family member with prolonged QT syndrome. QTc interval >490 msec when 3 consecutive ECG values are averaged.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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