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Non Small Cell Lung CancerNCT04640870

The Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib

An observational study of Non Small Cell Lung Cancer and EGF-R Positive Non-Small Cell Lung Cancer, run by Hellenic Cooperative Oncology Group.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an observational, non-interventional, single-country, multi center, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC) who had been treated with Afatinib at… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Afatinib
How many people
59 participants
Where
No sites listed yet
Study dates
15 Mar 2015to May 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This is a retrospective analysis of patients with histologically confirmed Non-small cell lung cancer and EGFR mutated, with progressive disease. Patients analysed in this study have been treated with Afatinib in any line. Patients have been treated in Hellenic Cooperative Oncology Group(HeCOG)- affiliated departments of oncology.

Who may be able to join

  • >18 years old
  • Patients diagnosed with Non-small cell lung cancer
  • metastatic disease
  • Afatinib treated in any line
  • EGFR mutated

Who cannot join

  • -

About this study

Official title: An Observational Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib in Real-world Clinical Set-tings in Greece

This is an observational, non-interventional, single-country, multi center, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC) who had been treated with Afatinib at any line.

Read the detailed description

This is an observational, non-interventional, single-country, multicenter, retrospective cohort study, based on real world data collection, of patients with locally advanced or metastatic EGFR mutation-positive NSCLC who had been treated with Afatinib s at any line.

The study is carried out by hospital-based oncologists/pneumonologists specializing in lung cancer under real-world conditions of daily clinical practice. Investigators were selected through a documented and structured feasibility process which accounted for physicians' qualifications, previous participation and experience in similar clinical studies, recruitment potential, and retention capability. In addition, in order to represent variations in current real-world patterns of care, research sites were recruited from various geographic regions in Greece, also taking into consideration the regional setting and type of healthcare site/institution (publicly/privately owned, specialized oncology/pulmonology clinic, university clinic).

Being tested
Afatinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AfatinibDrug

    Treatment with Afatinib, any line, in metastatic, EGFR mutated patients with NSCLC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression Free Survival

    Measured: From Day 1 of treatment with Afatinib until disease progression, death from any cause or last follow-up, whichever occurs first, up to 12 months

Secondary outcomes (3)

  1. Overall survival

    Overall survival

    Measured: From Day 1 of treatment with Afatinib until death from any cause or last follow-up, up to 24 months

  2. Second progression-free survival (PFS2)

    Second progression-free survival (PFS2)

    Measured: From the initiation of next treatment following discontinuation of Afatinib to the date of progression, death or last contact, up to 6 months

  3. Assessment of the safety profile of Afatinib

    assessment of the safety profile of Afatinib

    Measured: In every cycle, every 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2020
  2. Study start15 Mar 2015
  3. Primary completionMar 2020
  4. Study completionMay 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04640870
Sponsor's protocol ID
ΗΕ2/15
Status last verified
Nov 2020
First submitted
12 Nov 2020
Last updated
23 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Planchard D, Popat S, Kerr K, Novello S, Smit EF, Faivre-Finn C, Mok TS, Reck M, Van Schil PE, Hellmann MD, Peters S; ESMO Guidelines Committee. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv192-iv237. doi: 10.1093/annonc/mdy275. No abstract available.

    PubMed 30285222

  • Maemondo M, Inoue A, Kobayashi K, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Ogura T, Ando M, Miyazawa H, Tanaka T, Saijo Y, Hagiwara K, Morita S, Nukiwa T; North-East Japan Study Group. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010 Jun 24;362(25):2380-8. doi: 10.1056/NEJMoa0909530.

    PubMed 20573926

  • Mitsudomi T, Morita S, Yatabe Y, Negoro S, Okamoto I, Tsurutani J, Seto T, Satouchi M, Tada H, Hirashima T, Asami K, Katakami N, Takada M, Yoshioka H, Shibata K, Kudoh S, Shimizu E, Saito H, Toyooka S, Nakagawa K, Fukuoka M; West Japan Oncology Group. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol. 2010 Feb;11(2):121-8. doi: 10.1016/S1470-2045(09)70364-X. Epub 2009 Dec 18.

    PubMed 20022809

  • Inoue A, Kobayashi K, Maemondo M, Sugawara S, Oizumi S, Isobe H, Gemma A, Harada M, Yoshizawa H, Kinoshita I, Fujita Y, Okinaga S, Hirano H, Yoshimori K, Harada T, Saijo Y, Hagiwara K, Morita S, Nukiwa T; North-East Japan Study Group. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin-paclitaxel for chemo-naive non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013 Jan;24(1):54-9. doi: 10.1093/annonc/mds214. Epub 2012 Sep 11.

    PubMed 22967997

  • Wu YL, Zhou C, Hu CP, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Lee KY, Xu CR, Massey D, Kim M, Shi Y, Geater SL. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Feb;15(2):213-22. doi: 10.1016/S1470-2045(13)70604-1. Epub 2014 Jan 15.

    PubMed 24439929

  • Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Munoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Francais de Pneumo-Cancerologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

    PubMed 22285168

  • Paz-Ares L, Tan EH, O'Byrne K, Zhang L, Hirsh V, Boyer M, Yang JC, Mok T, Lee KH, Lu S, Shi Y, Lee DH, Laskin J, Kim DW, Laurie SA, Kolbeck K, Fan J, Dodd N, Marten A, Park K. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017 Feb 1;28(2):270-277. doi: 10.1093/annonc/mdw611.

    PubMed 28426106

  • Park K, Tan EH, O'Byrne K, Zhang L, Boyer M, Mok T, Hirsh V, Yang JC, Lee KH, Lu S, Shi Y, Kim SW, Laskin J, Kim DW, Arvis CD, Kolbeck K, Laurie SA, Tsai CM, Shahidi M, Kim M, Massey D, Zazulina V, Paz-Ares L. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016 May;17(5):577-89. doi: 10.1016/S1470-2045(16)30033-X. Epub 2016 Apr 12.

    PubMed 27083334

  • Wu YL, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Tsuji F, Linke R, Rosell R, Corral J, Migliorino MR, Pluzanski A, Sbar EI, Wang T, White JL, Nadanaciva S, Sandin R, Mok TS. Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1454-1466. doi: 10.1016/S1470-2045(17)30608-3. Epub 2017 Sep 25.

    PubMed 28958502

  • Mok TS, Cheng Y, Zhou X, Lee KH, Nakagawa K, Niho S, Lee M, Linke R, Rosell R, Corral J, Migliorino MR, Pluzanski A, Sbar EI, Wang T, White JL, Wu YL. Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations. J Clin Oncol. 2018 Aug 1;36(22):2244-2250. doi: 10.1200/JCO.2018.78.7994. Epub 2018 Jun 4.

    PubMed 29864379

  • Wang J, Wang B, Chu H, Yao Y. Intrinsic resistance to EGFR tyrosine kinase inhibitors in advanced non-small-cell lung cancer with activating EGFR mutations. Onco Targets Ther. 2016 Jun 22;9:3711-26. doi: 10.2147/OTT.S106399. eCollection 2016.

    PubMed 27382309

  • Gainor JF, Shaw AT. Emerging paradigms in the development of resistance to tyrosine kinase inhibitors in lung cancer. J Clin Oncol. 2013 Nov 1;31(31):3987-96. doi: 10.1200/JCO.2012.45.2029. Epub 2013 Oct 7.

    PubMed 24101047

  • Kim HR, Cho BC, Shim HS, Lim SM, Kim SK, Chang J, Kim DJ, Kim JH. Prediction for response duration to epidermal growth factor receptor-tyrosine kinase inhibitors in EGFR mutated never smoker lung adenocarcinoma. Lung Cancer. 2014 Mar;83(3):374-82. doi: 10.1016/j.lungcan.2013.12.011. Epub 2014 Jan 3.

    PubMed 24468202

  • Levy BP, Rao P, Becker DJ, Becker K. Attacking a Moving Target: Understanding Resistance and Managing Progression in EGFR-Positive Lung Cancer Patients Treated With Tyrosine Kinase Inhibitors. Oncology (Williston Park). 2016 Jul;30(7):601-12.

    PubMed 27432364

  • Cortot AB, Janne PA. Molecular mechanisms of resistance in epidermal growth factor receptor-mutant lung adenocarcinomas. Eur Respir Rev. 2014 Sep;23(133):356-66. doi: 10.1183/09059180.00004614.

    PubMed 25176972

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer and EGF-R Positive Non-Small Cell Lung Cancer, run by Hellenic Cooperative Oncology Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: From Day 1 of treatment with Afatinib until disease progression, death from any cause or last follow-up, whichever occurs first, up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04640870, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.

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