Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer

Non-Small Cell Carcinoma of Lung, TNM Stage 4 Clinical Trial

— SNF-CLIMEDIN  

Official title:

Clinical and Molecular Study With Digital Support of Patients With Inoperable Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05372081
• Other study ID #: HE2SN/21
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: March 2025

Study information

• Verified date: April 2022
• Source: Hellenic Cooperative Oncology Group
• Contact: Paris Kosmidis, MD
• Phone: +30 210 6867105
• Email: parkosmi[@]otenet.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to provide high quality oncology services to patients with inoperable Non-Small Cell Lung Cancer (NSCLC) in Greece. These services will be based on 3 pillars: 1. Clinical: personalized treatment will be administered and its effectiveness and safety will be recorded and evaluated. 2. Molecular: the gene footprint of each patient at the beginning of his treatment, the molecular identity of his tumor will be analyzed and recorded based on analysis with modern Next Generation Sequencing (NGS) techniques. 3. Digital: Patients will have access to the digital platform where they will record the adverse reactions they will face during their treatment.

Description:

Lung cancer is the primary cause of cancer death worldwide regardless of gender or age group. Based on the most recent statistics for our country, every year about 9000 new cases of lung cancer are diagnosed. Lung cancer is the most common type of cancer in Greece in both men and women. It is estimated that about 8000 people lose their lives annually from this disease, while the total number of deaths from lung cancer seems to exceed in number the sum of deaths due to breast, prostate and colorectal cancer. For many decades chemotherapy was the cornerstone and the only treatment option for lung cancer. In the last 20 years, the discovery and study of various molecular subtypes in non-small cell lung cancer has led to the development of targeted therapies. Modern oncology has multiple targeted therapies for corresponding molecular subtypes, such as ROS-1 rearrangements, amplifications and mutations of the MET gene, RET rearrangements, mutations of the BRAF gene, NTRK gene fusions, HER2 gene mutations, as well as KRAS mutations.The detection of molecular pathways, targeted mutations and biomarkers is a critical step in the diagnosis and treatment of patients with non-small cell lung cancer, in both early and advanced stage.The use of NGS (Next Generation Sequencing) technology as modern tool for accessing genetic material is adopted by more and more clinicians worldwide. The molecular analysis of the tumor with the technique of NGS, is considered as a necessity in the practice of modern oncology in order the patients to receive the best treatments for their disease. a) Clinical pillar: In this study will be included 200 patients, 18 years old and older, with PS 0-2, treated for inoperable NSCLC stage IV. Patient will be treated according to the local standard of care based on their medical history. b)After signing the Informed Consent patients will provide biological material (blood samples and Formalin fixed paraffin embedded tissues) in order to proceed with the molecular arm of the study and the extended NGS analysis. In addition to molecular analysis, an economic analysis of the use of health resources will follow for a detailed understanding of the relevant financial aggregates and the improvement of the performance of existing resources. c) On the digital arm each patient will have access in the digital platform of CAREACCROSS which allows continuous and remote access for both patient and their physician with absolute security and data privacy. All patients will be included in the digital monitoring and information program from their mobile phone and will have contact the investigator and the study team.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with non-small cell lung cancer stage IV
• No younger than 18 years old patients
• Performance status: 0-2
• Existence of biological material for the molecular analysis
• Patients who have not been treated with any other treatment than adjuvant
• Ability to use a mobile device or computer for digital communication

Exclusion Criteria:

• Childbearing women
• Patients with PS > 3
• Limited ability to use a mobile device for basic digital communication

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Carcinoma of Lung, TNM Stage 4

Intervention

Other:
• Digital platform
Patients will be randomized (1:1) in the way they will receive or not any assistance from the digital platform.

Locations

Country	Name	City	State
Greece	1st Dept of Medical Oncology, Metropolitan Hospital	Athens
Greece	2nd Dept of Medical Oncology, Metropolitan Hospital	Athens
Greece	3rd Dept of Medical Oncology, Agii Anargiri Cancer Hospital	Athens	Nea Kifisia
Greece	401 General Military Hospital of Athens	Athens
Greece	4th Dept of Medical Oncology, Metropolitan Hospital	Athens	Neo Faliro
Greece	EUROCLINIC of Athens	Athens
Greece	Henry Dunant Hospital Center	Athens
Greece	MITERA Hospital	Athens	Marousi
Greece	General Hospital of Kavalas	Kavála
Greece	General University Hospital of Larissa	Larissa	Mezourlo
Greece	Division of Oncology, Dept of Internal Medicine, University Hospital of Patras	Patra
Greece	General Hospital of Patra "Agios Andreas"	Patra
Greece	Ygeia Hospital	Psychikó	Attiki
Greece	2nd Dept of Medical Oncology, EUROMEDICA General Clinic of Thessaloniki	Thessaloníki
Greece	General Hospital of Thessalonikis "G. Papanikolaou"	Thessaloníki

Sponsors (3)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group	Care Across Ltd, Stavros Niarchos Foundation

Country where clinical trial is conducted

Greece, 

References & Publications (16)

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Kandoth C, McLellan MD, Vandin F, Ye K, Niu B, Lu C, Xie M, Zhang Q, McMichael JF, Wyczalkowski MA, Leiserson MDM, Miller CA, Welch JS, Walter MJ, Wendl MC, Ley TJ, Wilson RK, Raphael BJ, Ding L. Mutational landscape and significance across 12 major cancer types. Nature. 2013 Oct 17;502(7471):333-339. doi: 10.1038/nature12634. — View Citation

Knijnenburg TA, Wang L, Zimmermann MT, Chambwe N, Gao GF, Cherniack AD, Fan H, Shen H, Way GP, Greene CS, Liu Y, Akbani R, Feng B, Donehower LA, Miller C, Shen Y, Karimi M, Chen H, Kim P, Jia P, Shinbrot E, Zhang S, Liu J, Hu H, Bailey MH, Yau C, Wolf D, Zhao Z, Weinstein JN, Li L, Ding L, Mills GB, Laird PW, Wheeler DA, Shmulevich I; Cancer Genome Atlas Research Network, Monnat RJ Jr, Xiao Y, Wang C. Genomic and Molecular Landscape of DNA Damage Repair Deficiency across The Cancer Genome Atlas. Cell Rep. 2018 Apr 3;23(1):239-254.e6. doi: 10.1016/j.celrep.2018.03.076. — View Citation

Lih CJ, Harrington RD, Sims DJ, Harper KN, Bouk CH, Datta V, Yau J, Singh RR, Routbort MJ, Luthra R, Patel KP, Mantha GS, Krishnamurthy S, Ronski K, Walther Z, Finberg KE, Canosa S, Robinson H, Raymond A, Le LP, McShane LM, Polley EC, Conley BA, Doroshow JH, Iafrate AJ, Sklar JL, Hamilton SR, Williams PM. Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial: Molecular Analysis for Therapy Choice Clinical Trial. J Mol Diagn. 2017 Mar;19(2):313-327. doi: 10.1016/j.jmoldx.2016.10.007. Epub 2017 Feb 7. — View Citation

Luthra R, Patel KP, Routbort MJ, Broaddus RR, Yau J, Simien C, Chen W, Hatfield DZ, Medeiros LJ, Singh RR. A Targeted High-Throughput Next-Generation Sequencing Panel for Clinical Screening of Mutations, Gene Amplifications, and Fusions in Solid Tumors. J Mol Diagn. 2017 Mar;19(2):255-264. doi: 10.1016/j.jmoldx.2016.09.011. Epub 2016 Dec 23. — View Citation

Mehrotra M, Duose DY, Singh RR, Barkoh BA, Manekia J, Harmon MA, Patel KP, Routbort MJ, Medeiros LJ, Wistuba II, Luthra R. Versatile ion S5XL sequencer for targeted next generation sequencing of solid tumors in a clinical laboratory. PLoS One. 2017 Aug 2;12(8):e0181968. doi: 10.1371/journal.pone.0181968. eCollection 2017. — View Citation

Osei, E., Lumini, J., Gunasekara, D., Osei, B., Asare, A., & Laflamme, R. (2020). A review of predictive, prognostic and diagnostic biomarkers for non-small-cell lung cancer: Towards personalised and targeted cancer therapy. Journal of Radiotherapy in Practice, 19(4), 370-384. doi:10.1017/S1460396919000876

Pfarr N, Kirchner M, Lehmann U, Leichsenring J, Merkelbach-Bruse S, Glade J, Hummel M, Stögbauer F, Lehmann A, Trautmann M, Kumbrink J, Jung A, Dietmaier W, Endris V, Kazdal D, Evert M, Horst D, Kreipe H, Kirchner T, Wardelmann E, Lassen U, Büttner R, Weichert W, Dietel M, Schirmacher P, Stenzinger A. Testing NTRK testing: Wet-lab and in silico comparison of RNA-based targeted sequencing assays. Genes Chromosomes Cancer. 2020 Mar;59(3):178-188. doi: 10.1002/gcc.22819. Epub 2019 Nov 18. — View Citation

Ricciuti B, Recondo G, Spurr LF, Li YY, Lamberti G, Venkatraman D, Umeton R, Cherniack AD, Nishino M, Sholl LM, Shapiro GI, Awad MM, Cheng ML. Impact of DNA Damage Response and Repair (DDR) Gene Mutations on Efficacy of PD-(L)1 Immune Checkpoint Inhibition in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Aug 1;26(15):4135-4142. doi: 10.1158/1078-0432.CCR-19-3529. Epub 2020 Apr 24. — View Citation

Rothberg JM, Hinz W, Rearick TM, Schultz J, Mileski W, Davey M, Leamon JH, Johnson K, Milgrew MJ, Edwards M, Hoon J, Simons JF, Marran D, Myers JW, Davidson JF, Branting A, Nobile JR, Puc BP, Light D, Clark TA, Huber M, Branciforte JT, Stoner IB, Cawley SE, Lyons M, Fu Y, Homer N, Sedova M, Miao X, Reed B, Sabina J, Feierstein E, Schorn M, Alanjary M, Dimalanta E, Dressman D, Kasinskas R, Sokolsky T, Fidanza JA, Namsaraev E, McKernan KJ, Williams A, Roth GT, Bustillo J. An integrated semiconductor device enabling non-optical genome sequencing. Nature. 2011 Jul 20;475(7356):348-52. doi: 10.1038/nature10242. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Molecular identification of patients with non-small cell lung cancer		up to 36 months
Secondary	Overall survival		up to 36 months
Secondary	Data correlation		up to 36 months