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

NCT03512847 | Completed DMC

• 1 other identifier: REG-006-2018
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Nonsmall Cell Lung Cancer

Keywords

liquid biopsy; genomic profiling; ctDNA

Outcome Measures

Primary Outcomes (3)

• Predictive gene profiles

  Concordance between specific gene profiles and treatment outcomes

  until progression or death, an average of 3 years

• Resistance mechanisms toward chemotherapy and immunotherapy

  Differences in molecular profiles pre- and post-treatment

  until progression or death, an average of 3 years

• ctDNA as a dynamic biomarker

  Quantification of ctDNA during treatment linked to treatment outcome

  until progression or death, an average of 3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Metastatic non-small cell lung cancer.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Oncology

Næstved, Region Sjælland, Denmark

Location

Related Publications (2)

• Frank MS, Andersen CSA, Ahlborn LB, Pallisgaard N, Bodtger U, Gehl J. Circulating Tumor DNA Monitoring Reveals Molecular Progression before Radiologic Progression in a Real-life Cohort of Patients with Advanced Non-small Cell Lung Cancer. Cancer Res Commun. 2022 Oct 13;2(10):1174-1187. doi: 10.1158/2767-9764.CRC-22-0258. eCollection 2022 Oct.

  PMID: 36969747 DERIVED

• 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.

  PMID: 32949828 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Comprehensive molecular profiling. Whole Exome Sequencing

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Frank S Malene, MD

  Region Zeland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: May 1, 2018
• Study Start: May 29, 2018
• Primary Completion: November 6, 2022
• Study Completion: November 6, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Locations

DK (1)