Prospective Evaluation of Immunological, Molecular-genetic, Image-based and Microbial Analyzes to Characterize Tumor Response and Control in Patients With Inoperable Stage III NSCLC Treated With Chemoradiotherapy Followed by Consolidation Therapy With Durvalumab

Summary

This non-interventional single-center explorative biomarker study aims at longitudinal comprehensive characterization (molecular genetics, immunological, morphological, image-based and microbial features) of the patient (host) and tumor as well as changes during standard treatment and in case of recurrent disease in inoperable stage III non-small cell lung cancer (NSCLC). Comprehensive analysis will include peripheral blood cellular and humoral immunophenotyping, circulating tumor DNA and gut/saliva microbiota analyses. 18F-FDG-PET/CT before, 6 weeks, 6- and 12-months after chemoradiotherapy as well as daily in course of radiation treatment cone-beam-CT and/or MRI imaging are included for morphological analysis. This study will provide valuable information of predictive biomarkers in patients with stage III NSCLC treated with durvalumab maintenance treatment after concurrent chemoradiotherapy.

Conditions

• Oncology
• Biomarker
• NSCLC, Stage III
• Durvalumab
• Chemoradiotherapy

Interventions

OTHER

Non-interventional

No intervention

Sponsors & Collaborators

• Department of Internal Medicine V, Thoracic Oncology Centre Munich, LMU Munich, Munich, Germany

  collaborator UNKNOWN

• Institute of Pathology, Faculty of Medicine, LMU Munich, Munich, Germany

  collaborator UNKNOWN

• Asklepios Lung Clinic, Munich-Gauting, Germany

  collaborator UNKNOWN

• Department of Radiology, University Hospital, LMU Munich, Munich, Germany

  collaborator UNKNOWN

• Department of Nuclear Medicine, University Hospital, LMU Munich, Munich, Germany

  collaborator UNKNOWN

• Institute for Medical Information Processing, Biometry and Epidemiology, LMU München, Munich, Germany

  collaborator UNKNOWN

• Department of Medicine II, University Hospital, LMU Munich, Munich, Germany

  collaborator UNKNOWN

• Immunoanalytics Research Group Tissue Control of Immunocytes, Helmholtz Center Munich, Munich, Germany

  collaborator UNKNOWN

• LMU Klinikum

  lead OTHER

Principal Investigators

• Farkhad Manapov, PhD MD · LMU University hospital, Munich, Germany

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-07

Primary Completion

2024-01-31

Completion

2025-01-31

FDA Drug

Yes

Countries

• Germany

Study Locations