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Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer

Z

Zealand University Hospital

Status

Completed

Conditions

Metastatic Nonsmall Cell Lung Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT03512847
REG-006-2018

Details and patient eligibility

About

The study aims include:

  • Exploring potential predictive molecular profiles to immunotherapy/chemotherapy
  • Investigating the role of circulating tumor DNA as a dynamic biomarker during immunotherapy/chemotherapy
  • Identifying possible resistance mechanisms to immunotherapy/chemotherapy

Materials and methods:

Approximately 150 patients diagnosed with metastatic NSCLC assigned for immunotherapy or chemotherapy will be candidates for inclusion during a 1-2 years period.

A comprehensive molecular profiling will be made from the diagnostic biopsy. Before every treatment-cycle a blood sample will be taken to quantify ctDNA. At time of progressive disease during/after first line treatment, patients will be asked to participate in a new biopsy and a comprehensive molecular profiling will be performed.

The tissue and blood samples collected will be stored in a biobank. Clinical data will be collected to perform a comprehensive database.

Analysis:

Potentially predictive molecular profiles for immunotherapy/chemotherapy will be found by comparison of treatment outcome for patients with specific molecular characteristics.

Through quantification of ctDNA during treatment and upon progression, the role of ctDNA as a dynamic biomarker will be further strengthened.

Differences in molecular profiles pre- and post-treatment may reveal resistance mechanisms to treatment. Molecular profiling on progression can be valuable in second-line treatment guidance.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 18 years
  • Able to understand and read Danish
  • WHO Performance status 0-2
  • Acceptable organ function (liver/kidney/heart) for treatment
  • The disease has to be:

evaluable or measurable according to RECIST/iRECIST accessible for biopsy metastatic or not suitable for curative intended treatment

Exclusion criteria

  • Other active cancers
  • Contraindications for systemic therapy
  • ALK-positive, ROS-1 or EGFR mutations

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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