NCT03197467

Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer

Neoadjuvant Anti PD-1 Immunotherapy in Resectable Non-small Cell Lung Cancer [NEOMUN]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

NEOMUN is designed as an open-label, single arm, prospective, monocenter, phase II study of pembrolizumab in a neoadjuvant setting in patients with non-small cell lung cancer of Stage II/IIIA suitable for curative intent surgery.

Detailed description

The study is designed as an open-label, single arm, prospective, monocenter, phase II study of pembrolizumab in a neoadjuvant setting in patients with resectable NSCLC stage II/IIIA suitable for curative intent surgery, taking place in Germany. Planned sample size is N=30. Investigational drug is Pembrolizumab at fixed dose, given 200 mg q3w i.v. for 2 cycles. After completion of immunotherapy lobectomy/ bilobectomy with curative intent is scheduled. Primary objectives are to assess feasibility and safety of a neoadjuvant application of pembrolizumab and to assess antitumor activity of pembrolizumab with regard to clinical and pathologic tumor response. Secondary objective is to assess the impact of neoadjuvant pembrolizumab on patient disease free and overall survival. Exploratory objective is o explore potential predictive biomarkers for pembrolizumab efficacy (immune cell imaging).

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles

Timeline

• Start date: 2018-06-18
• Primary completion: 2021-10-30
• Completion: 2023-05-05
• First posted: 2017-06-23
• Last updated: 2025-04-04
• Results posted: 2025-04-04

Locations

1 site across 1 country: Germany