Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

The study will enrol 40 patients with stage III inoperable non-small cell lung cancer (NSCLC) who received standard chemoradiotherapy followed by maintenance therapy with PD-L1 inhibition (durvalumab) according to the current European Medicines Agency (EMA) approval. The oncological treatment is carried out according to the international standards of radiation oncology/medical oncology. These are implemented by the department of radiation oncology at the University Hospital Munich (LMU) in their SOPs. Therefore, all patients will be treated with concurrent platinum-based chemoradiotherapy followed by durvalumab maintenance treatment 12 months after the end of chemoradiotherapy at the department of radiation oncology (University Hospital Munich (LMU)). Comprehensive characterization of all patients includes immunophenotyping of peripheral blood mono-nuclear cells, ctDNA as well as gut/saliva microbiome analyses and will be performed before, after 15 fractions of radiotherapy, at the end of concurrent chemoradiotherapy as well as 3-, 6- and 12 months after start of durvalumab. 18F-FDG-PET/CT will be performed 5-10 d before start of radiotherapy, 6 weeks, 6 months,12 and 24 months after the end of chemoradiotherapy. Lung function will be assessed before start of radiotherapy, at the end and 6 weeks after chemoradiotherapy as well as 3-, 6- and 12, 18, 24 months after start of durvalumab. Follow-up will be performed by the department of radiation oncology at the University Hospital Munich (LMU) according to the clinical SOPs. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05027165
Study type Observational
Source LMU Klinikum
Contact
Status Active, not recruiting
Phase
Start date November 7, 2020
Completion date January 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT01439152 - Phase I Study to Determine the Maximum Tolerable Dose of BAY94-9343 in Patients With Advanced Solid Tumors. Phase 1
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Active, not recruiting NCT06015009 - Symptom Management App for Children at the Early Stage of Cancer Survivorship and Their Caregivers N/A
Active, not recruiting NCT03298100 - Risk Scoring Model for Endometrial Cancer
Recruiting NCT05055609 - Open-Label, Dose-Escalation With Expansion to Assess the Safety, Tolerability, and PK of TRE-515 in Subjects With Solid Tumors Phase 1
Not yet recruiting NCT04324320 - Psychological Distress in Outpatient Oncological Rehabilitation
Completed NCT00588289 - Long Term Follow-Up of Patients on Children's Cancer Group Protocols- (CCG-LTF1) FOLLOW-UP DATA N/A
Recruiting NCT06222801 - The 1st Tumor CytokinoTherapy Database (TCTD-1)
Recruiting NCT03831633 - Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Phase 4
Completed NCT04914702 - Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.
Recruiting NCT05198570 - Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Recruiting NCT05712174 - A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer Phase 2
Recruiting NCT03832062 - Value of Analysing Under-utilised Leftover Tissue (VauLT)
Completed NCT03988777 - Magnetic Seed Localisation for Nonpalpable Breast Lesions
Recruiting NCT06031233 - Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie Phase 4
Enrolling by invitation NCT04019119 - Digital Intervention for the Modification of Lifestyles (iGame) N/A
Not yet recruiting NCT05926362 - Capillary-Venous Paired Data Collection
Recruiting NCT05510856 - Comparative Clinical Study Evaluating the Possible Efficacy of Duloxetine, Gabapentin and Lacosamide on Oxaliplatin-Induced Peripheral Neuropathy in Cancer Patients Phase 4
Recruiting NCT05686213 - ExeNTrO: Exercise During Neoadjuvant Chemoradiation Treatment to Improve Rectal and Esophageal Cancer Outcome - Pilot Trial Phase 2
Completed NCT04180306 - PEWS Implementation in an LMIC Setting N/A