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History of Changes for Study: NCT03512847
Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
Latest version (submitted February 8, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 30, 2018 None (earliest Version on record)
2 May 29, 2018 Recruitment Status, Study Status and Contacts/Locations
3 May 30, 2018 Study Status
4 July 3, 2019 Study Status
5 April 20, 2021 Recruitment Status, Study Status and Contacts/Locations
6 February 8, 2022 Study Status
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Study NCT03512847
Submitted Date:  April 30, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: REG-006-2018
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2018
Overall Status: Not yet recruiting
Study Start: April 2018
Primary Completion: January 2021 [Anticipated]
Study Completion: January 2021 [Anticipated]
First Submitted: March 26, 2018
First Submitted that
Met QC Criteria:
April 30, 2018
First Posted: May 1, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
April 30, 2018
Last Update Posted: May 1, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Zealand University Hospital
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Metastatic Nonsmall Cell Lung Cancer
Keywords: liquid biopsy
genomic profiling
ctDNA
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Comprehensive molecular profiling. Whole Exome Sequencing
Enrollment: 150 [Anticipated]
Number of Groups/Cohorts 0
Open or close this module Groups and Interventions
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Predictive gene profiles
[ Time Frame: until progression or death, an average of 3 years ]

Concordance between specific gene profiles and treatment outcomes
2. 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
3. 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
Open or close this module Eligibility
Study Population: Metastatic non-small cell lung cancer.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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