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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512847
Recruitment Status : Active, not recruiting
First Posted : May 1, 2018
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Tracking Information
First Submitted Date March 26, 2018
First Posted Date May 1, 2018
Last Update Posted Date February 9, 2022
Actual Study Start Date May 29, 2018
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2018)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Comprehensive molecular profiling. Whole Exome Sequencing
Sampling Method Non-Probability Sample
Study Population Metastatic non-small cell lung cancer.
Condition Metastatic Nonsmall Cell Lung Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Frank MS, Bødtger U, Høegholm 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: April 30, 2018)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT03512847
Other Study ID Numbers REG-006-2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Zealand University Hospital
Original Responsible Party Same as current
Current Study Sponsor Zealand University Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Frank S Malene, MD Region Zeland
PRS Account Zealand University Hospital
Verification Date April 2021