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

NCT04875585 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-08-24

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

neoadjuvant therapy with Pembrolizumab/Lenvatinib

Neoadjuvant therapy for 6 weeks

PROCEDURE

Surgery

surgical resection of primary tumor and lymph-node-dissection.

DRUG

Adjuvant Treatment Phase

Adjuvant treatment with 15 cycles of Pembrolizumab

Sponsors & Collaborators

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-12
Primary Completion
2023-12-31
Completion
2027-12-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875585 on ClinicalTrials.gov