Clinical trial NCT03512847: Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
Official title: Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Nonsmall Cell Lung Cancer
Keywords: liquid biopsy
genomic profiling
ctDNA
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metastatic non-small cell lung cancer.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Predictive gene profiles
timeFrame: until progression or death, an average of 3 years
measure: Resistance mechanisms toward chemotherapy and immunotherapy
timeFrame: until progression or death, an average of 3 years
measure: ctDNA as a dynamic biomarker
timeFrame: until progression or death, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Naestved
country: Denmark
facility: Department of Oncology
state: Zealand
Study officials:
affiliation: Region Zeland
name: Frank S Malene, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frank MS, Bodtger U, Hoegholm A, Stamp IM, Gehl J. Re-biopsy after first line treatment in advanced NSCLC can reveal changes in PD-L1 expression. Lung Cancer. 2020 Nov;149:23-32. doi: 10.1016/j.lungcan.2020.08.020. Epub 2020 Sep 12.