NCT03512847

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

Completed Last updated 6 February 2023

What this trial tests

trial in Metastatic Nonsmall Cell Lung Cancer in 150 participants. Completed in 6 November 2022.

Timeline

29 May 2018

Primary endpoint
6 November 2022

6 November 2022

Quick facts

Lead sponsor	Zealand University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	29 May 2018
Primary completion	6 November 2022
Estimated completion	6 November 2022
Sites	1 location across Denmark

Conditions studied

• Metastatic Nonsmall Cell Lung Cancer — all drugs for Metastatic Nonsmall Cell Lung Cancer →

Sponsor

Zealand University Hospital

Who can join

18 and older, any sex, with Metastatic Nonsmall Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Failure of Immunotherapy-The Molecular and Immunological Origin of Immunotherapy Resistance in Lung Cancer.
   Błach J, Wojas-Krawczyk K, Nicoś M, Krawczyk P. · · 2021 · cited 44× · PMID 34445735 · DOI 10.3390/ijms22169030
2. Circulating Biomarkers of Response and Toxicity of Immunotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC): A Comprehensive Review.
   Indini A, Rijavec E, Grossi F. · · 2021 · cited 39× · PMID 33918661 · DOI 10.3390/cancers13081794
3. Prognostic and Predictive Biomarkers in Non-Small Cell Lung Cancer Patients on Immunotherapy-The Role of Liquid Biopsy in Unraveling the Puzzle.
   Augustus E, Zwaenepoel K, Siozopoulou V, Raskin J, et al · · 2021 · cited 21× · PMID 33918147 · DOI 10.3390/cancers13071675
4. Circulating Tumor DNA Monitoring Reveals Molecular Progression before Radiologic Progression in a Real-life Cohort of Patients with Advanced Non-small Cell Lung Cancer.
   Frank MS, Andersen CSA, Ahlborn LB, Pallisgaard N, et al · · 2022 · cited 18× · PMID 36969747 · DOI 10.1158/2767-9764.crc-22-0258
5. Re-biopsy after first line treatment in advanced NSCLC can reveal changes in PD-L1 expression.
   Frank MS, Bødtger U, Høegholm A, Stamp IM, et al · · 2020 · cited 17× · PMID 32949828 · DOI 10.1016/j.lungcan.2020.08.020
6. Clinical Efficacy and Future Prospects of Immunotherapy in Lung Cancer.
   Kinoshita T, Terai H, Yaguchi T. · · 2021 · cited 16× · PMID 34685400 · DOI 10.3390/life11101029
7. BESPOKE IO protocol: a multicentre, prospective observational study evaluating the utility of ctDNA in guiding immunotherapy in patients with advanced solid tumours.
   Kasi PM, Chakrabarti S, Sawyer S, Krainock M, et al · · 2022 · cited 9× · PMID 35636789 · DOI 10.1136/bmjopen-2021-060342
8. Actionable Molecular Alterations Are Revealed in Majority of Advanced Non-Small Cell Lung Cancer Patients by Genomic Tumor Profiling at Progression after First Line Treatment.
   Frank MS, Bodtger U, Gehl J, Ahlborn LB. · · 2021 · cited 7× · PMID 35008297 · DOI 10.3390/cancers14010132