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AzTrials

Non-small Cell Lung CancerKey-EarlyNCT06467383

A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced

An observational study of Non-small Cell Lung Cancer and NSCLC, run by MSD Italia S.r.l. at 25 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have/had non-small cell lung cancer (NSCLC), either early stage (stage I-II). Read more about this study

Who is it for?
Ages 18 years and older
How many people
600 participants
Where
25 sitesItaly
Study dates
25 Jun 2024to 24 Jun 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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: The study population will consist of patients with early stage and locally advanced NSCLC (stage I-III) who had completed curative treatment planning and subsequent at least 18-months follow-up between January 2018 and January 2021.

Who may be able to join

  • Patients with stage I-III NSCLC who have received curative surgery or radiotherapy between January 2018 and June 2019 with available follow-up through January 2021
  • Adult patients (aged ≥ 18 years) at the moment of diagnosis
  • Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent form; privacy Form (ICF). In case of deceased or untraceable patient the investigator before collecting data shall demonstrate and report all necessary measures adopted to contact the patient.

Who cannot join

  • Patients without availability of medical charts or information required
  • Enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Daniele Righi, PM contact

+39 051 5878211

d.righi@yghea.it

25 sites in 1 country

Italy25 sites, 25 recruiting

  • ASST degli Spedali Civili di Brescia

    Brescia

    Salvatore Grisanti, MD

    Not yet recruiting

  • Gemelli Molise

    Campobasso

    Andrea Mancuso Petricca, MD

    Not yet recruiting

  • Humanitas Istituto Clinico Catanese

    Catania

    Michele Caruso, MD

    Not yet recruiting

  • Policlinico Rodolico

    Catania

    Hector Soto Parra, MD

    Not yet recruiting

  • AOU Careggi

    Florence

    Lorenzo Antonuzzo, MD

    Recruiting

  • IRCCS Policlinico S. Martino

    Genova

    Carlo Genova, MD

    Recruiting

  • AO Papardo

    Messina

    Alessandro Russo, MD

    Not yet recruiting

  • IRCCS Ospedale San Raffaele

    Milan

    Giulia Veronesi, MD

    Recruiting

  • Istituto Clinico Humanitas

    Milan

    Sabrina Rossi, MD

    Recruiting

  • Istituto Nazionale dei Tumori - Fondazione IRCCS

    Milan

    Giuseppe Lo Russo, MD

    Not yet recruiting

  • AOU dei Colli - Monaldi

    Naples

    Danilo Rocco, MD

    Not yet recruiting

  • AOU Vanvitelli

    Naples

    Floriana Morgillo, MD

    Recruiting

  • A.O.U. Maggiore della Carità di Novara

    Novara

    Gloria Borra, MD

    Recruiting

  • IOV - Istituto Oncologico veneto - IRCCS

    Padova

    Laura Bonanno, MD

    Not yet recruiting

  • AOUP Policlinico Giaccone

    Palermo

    Antonio Russo, MD

    Not yet recruiting

  • Azienda Ospedaliera Perugia - Ospedale S. Maria della MIsericordia

    Perugia

    Maria Francesca Currà

    Not yet recruiting

  • Azienda USL Toscana Centro - Ospedale san Jacopo

    Pistoia

    Mauro Iannopollo, MD

    Recruiting

  • Centro di Riferimento Oncologico IRCCS

    Pordenone

    Brigida Stanzione, MD

    Not yet recruiting

  • Azienda Ospedaliera Regionale San Carlo di Potenza

    Potenza

    Domenico Bilancia, MD

    Not yet recruiting

  • AUSL Romagna Ospedale Santa Maria delle Croci Ravenna

    Ravenna

    Chiara Bennati, MD

    Not yet recruiting

  • IRCCS AUSL Reggio Emilia

    Reggio Emilia

    Francesca Zanelli, MD

    Not yet recruiting

  • Fondazione Policlinico Universitario "A. Gemelli"

    Roma

    Emilio Bria, MD

    Not yet recruiting

  • IRCCS Casa di sollievo dalla sofferenza

    San Giovanni Rotondo, FG

    Evaristo Maiello, MD

    Not yet recruiting

  • ASST dei Sette Laghi

    Varese

    Francesco Grossi, MD

    Not yet recruiting

  • AOUI Verona

    Verona

    Sara Pilotto, MD

    Not yet recruiting

Other trials in Italy

About this study

This is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have/had non-small cell lung cancer (NSCLC), either early stage (stage I-II).

Read the detailed description

Due to heterogeneity of patients with stage I-III Non Small Cell Lung Cancer (NSCLC), there is not a unique common therapeutic approach and there is no consensus about the optimal timing, sequencing and combination of surgery, chemotherapy and radiotherapy across the spectrum of early stage and locally advance disease. Consequently, the choice of local treatment modality can vary across countries and centers.

Keywords
NSCLC early stage, NSCLC locally advanced, retrospective observational study, Real-World Evidence
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What is being measured

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

  1. NSCLC treatment approaches in Real-World practice

    Percentage of patients undergoing to:

    1. surgical resection of the lung cancer with curative intent;
    2. definitive (chemo)radiotherapy (defined as any regimen of chemotherapy administered with concurrent radiotherapy)
    3. neoadjuvant treatment (4 cycles) before surgery
    4. adjuvant treatments (4 cycles) after surgery

    Measured: Restrospective data capture from January 2018 to January 2021.

  2. Percentage of patients discusses in multidisciplinary team

    Multidisciplinary team defined as the involvement of radiotherapy unit, pneumology and/or interventional pneumology unit in patient discussion.

    Measured: Restrospective data capture from January 2018 to January 2021

  3. Healthcare resource utilization aof different therapeutic approaches

    Healthcare resources used to manage the patients will be described in terms of lab tests and/or outpatient visits and/or drug therapy and/or diagnostic tests.

    Measured: Restrospective data capture from January 2018 to January 2021.

  4. Direct medical costs of different therapeutic approaches

    The cost of the therapeutic approach (cost of illness) will be estimated through an activity-based costing (ABC) technique which allows to calculate the full cost of a service by measuring the cost of each individual activity/resource related to it.

    Measured: Restrospective data capture from January 2018 to January 2021.

Secondary outcomes (1)

  1. NSCLC treatments timeline in Real-World practice

    Median Time from:

    1. diagnosis/multidisciplinary referral to surgery or start of radioterapy
    2. surgery/completion of Radiotherapy to satrt of adjiuvant treatmen

    Measured: Restrospective data capture from January 2018 to January 2021.

Timeline

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

  1. First posted21 Jun 2024
  2. Study start25 Jun 2024
  3. Primary completion24 Jun 2025 (estimated)
  4. Study completion24 Jun 2025 (estimated)

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
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06467383
Sponsor's protocol ID
NIS009903
Acronym
Key-Early
Status last verified
Dec 2024
First submitted
14 Jun 2024
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.

    PubMed 31912902

  • Postmus PE, Kerr KM, Oudkerk M, Senan S, Waller DA, Vansteenkiste J, Escriu C, Peters S; ESMO Guidelines Committee. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv1-iv21. doi: 10.1093/annonc/mdx222. No abstract available.

    PubMed 28881918

  • Rosen JE, Keshava HB, Yao X, Kim AW, Detterbeck FC, Boffa DJ. The Natural History of Operable Non-Small Cell Lung Cancer in the National Cancer Database. Ann Thorac Surg. 2016 May;101(5):1850-5. doi: 10.1016/j.athoracsur.2016.01.077. Epub 2016 Apr 1.

    PubMed 27041452

  • Jin G, Wang X, Xu C, Sun J, Yuan Z, Wang J, Zhao L. Disparities in survival following surgery among patients with different histological types of N2-III non-small cell lung cancer: a Surveillance, Epidemiology and End Results (SEER) database analysis. Ann Transl Med. 2020 Oct;8(20):1288. doi: 10.21037/atm-20-4357.

    PubMed 33209868

  • Ball D, Mai GT, Vinod S, Babington S, Ruben J, Kron T, Chesson B, Herschtal A, Vanevski M, Rezo A, Elder C, Skala M, Wirth A, Wheeler G, Lim A, Shaw M, Schofield P, Irving L, Solomon B; TROG 09.02 CHISEL investigators. Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Lancet Oncol. 2019 Apr;20(4):494-503. doi: 10.1016/S1470-2045(18)30896-9. Epub 2019 Feb 12.

    PubMed 30770291

  • Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019 May 18;393(10185):2051-2058. doi: 10.1016/S0140-6736(18)32487-5. Epub 2019 Apr 11.

    PubMed 30982687

  • Senan S, Brade A, Wang LH, Vansteenkiste J, Dakhil S, Biesma B, Martinez Aguillo M, Aerts J, Govindan R, Rubio-Viqueira B, Lewanski C, Gandara D, Choy H, Mok T, Hossain A, Iscoe N, Treat J, Koustenis A, San Antonio B, Chouaki N, Vokes E. PROCLAIM: Randomized Phase III Trial of Pemetrexed-Cisplatin or Etoposide-Cisplatin Plus Thoracic Radiation Therapy Followed by Consolidation Chemotherapy in Locally Advanced Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Mar 20;34(9):953-62. doi: 10.1200/JCO.2015.64.8824. Epub 2016 Jan 25.

    PubMed 26811519

  • Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.

    PubMed 25601342

  • Benitez-Majano S, Fowler H, Maringe C, Di Girolamo C, Rachet B. Deriving stage at diagnosis from multiple population-based sources: colorectal and lung cancer in England. Br J Cancer. 2016 Jul 26;115(3):391-400. doi: 10.1038/bjc.2016.177. Epub 2016 Jun 21.

    PubMed 27328310

  • Blackstock AW, Govindan R. Definitive chemoradiation for the treatment of locally advanced non small-cell lung cancer. J Clin Oncol. 2007 Sep 10;25(26):4146-52. doi: 10.1200/JCO.2007.12.6581.

    PubMed 17827465

  • NSCLC Meta-analyses Collaborative Group; Arriagada R, Auperin A, Burdett S, Higgins JP, Johnson DH, Le Chevalier T, Le Pechoux C, Parmar MK, Pignon JP, Souhami RL, Stephens RJ, Stewart LA, Tierney JF, Tribodet H, van Meerbeeck J. Adjuvant chemotherapy, with or without postoperative radiotherapy, in operable non-small-cell lung cancer: two meta-analyses of individual patient data. Lancet. 2010 Apr 10;375(9722):1267-77. doi: 10.1016/S0140-6736(10)60059-1. Epub 2010 Mar 24.

    PubMed 20338627

  • Pignon JP, Tribodet H, Scagliotti GV, Douillard JY, Shepherd FA, Stephens RJ, Dunant A, Torri V, Rosell R, Seymour L, Spiro SG, Rolland E, Fossati R, Aubert D, Ding K, Waller D, Le Chevalier T; LACE Collaborative Group. Lung adjuvant cisplatin evaluation: a pooled analysis by the LACE Collaborative Group. J Clin Oncol. 2008 Jul 20;26(21):3552-9. doi: 10.1200/JCO.2007.13.9030. Epub 2008 May 27.

    PubMed 18506026

  • Salazar MC, Rosen JE, Wang Z, Arnold BN, Thomas DC, Herbst RS, Kim AW, Detterbeck FC, Blasberg JD, Boffa DJ. Association of Delayed Adjuvant Chemotherapy With Survival After Lung Cancer Surgery. JAMA Oncol. 2017 May 1;3(5):610-619. doi: 10.1001/jamaoncol.2016.5829.

    PubMed 28056112

  • Artal Cortes A, Calera Urquizu L, Hernando Cubero J. Adjuvant chemotherapy in non-small cell lung cancer: state-of-the-art. Transl Lung Cancer Res. 2015 Apr;4(2):191-7. doi: 10.3978/j.issn.2218-6751.2014.06.01.

    PubMed 25870801

  • Pisters KM, Vallieres E, Crowley JJ, Franklin WA, Bunn PA Jr, Ginsberg RJ, Putnam JB Jr, Chansky K, Gandara D. Surgery with or without preoperative paclitaxel and carboplatin in early-stage non-small-cell lung cancer: Southwest Oncology Group Trial S9900, an intergroup, randomized, phase III trial. J Clin Oncol. 2010 Apr 10;28(11):1843-9. doi: 10.1200/JCO.2009.26.1685. Epub 2010 Mar 15.

    PubMed 20231678

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer and NSCLC, run by MSD Italia S.r.l. at 25 sites in Italy.

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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Daniele Righi, PM (+39 051 5878211, d.righi@yghea.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NSCLC treatment approaches in Real-World practice (time frame: Restrospective data capture from January 2018 to January 2021.). The study lists 4 primary outcomes in all. 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 NCT06467383, which also lists 29 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 14 Jan 2025.

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