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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Nonsmall Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Oncology

Næstved, Region Sjælland, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Predictive gene profiles

Time frame: until progression or death, an average of 3 years

Concordance between specific gene profiles and treatment outcomes
Resistance mechanisms toward chemotherapy and immunotherapy

Time frame: until progression or death, an average of 3 years

Differences in molecular profiles pre- and post-treatment
ctDNA as a dynamic biomarker

Time frame: until progression or death, an average of 3 years

Quantification of ctDNA during treatment linked to treatment outcome

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: May 1, 2018
Registry last updated: Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed