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

Metastatic Nonsmall Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03512847
• Other study ID #: REG-006-2018
• Status: Completed
• Start date: May 29, 2018
• Est. completion date: November 6, 2022

Study information

• Verified date: February 2023
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 6, 2022
• Est. primary completion date: November 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Nonsmall Cell Lung Cancer

Locations

Country	Name	City	State
Denmark	Department of Oncology	Naestved	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive gene profiles	Concordance between specific gene profiles and treatment outcomes	until progression or death, an average of 3 years
Primary	Resistance mechanisms toward chemotherapy and immunotherapy	Differences in molecular profiles pre- and post-treatment	until progression or death, an average of 3 years
Primary	ctDNA as a dynamic biomarker	Quantification of ctDNA during treatment linked to treatment outcome	until progression or death, an average of 3 years