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| Name | Class |
|---|---|
| YGHEA, CRO Division of Ecol Studio spa | INDUSTRY |
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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).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| NSCLC treatment approaches in Real-World practice | Percentage of patients undergoing to:
| Restrospective data capture from January 2018 to January 2021. |
| 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. | Restrospective data capture from January 2018 to January 2021 |
| 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. | Restrospective data capture from January 2018 to January 2021. |
| 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. | Restrospective data capture from January 2018 to January 2021. |
| Measure | Description | Time Frame |
|---|---|---|
| NSCLC treatments timeline in Real-World practice | Median Time from:
| Restrospective data capture from January 2018 to January 2021. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers profile evaluation at NSCLC diagnosis | Percentage of PD-L1, EGFR/ALK, KRAS test performed along with results | Restrospective data capture from January 2018 to January 2021. |
| PD-L1 Biomarker profile evaluation at NSCLC diagnosis |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniele Righi, PM | Contact | +39 051 5878211 | d.righi@yghea.it |
| Name | Affiliation | Role |
|---|---|---|
| Giada Iuliano, MD | MSD Italia srl | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Casa di sollievo dalla sofferenza | Not yet recruiting | San Giovanni Rotondo | FG | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31912902 | Background | 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. | |
| 28881918 | Background | 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. |
| Label | URL |
|---|---|
| Globocan 2020 | View source |
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Percentage of PD-L1 test performed along with results
| Restrospective data capture from January 2018 to January 2021. |
| EGFR/ALK Biomarkers profile evaluation at NSCLC diagnosis | Percentage of EGFR/ALK test performed along with results | Restrospective data capture from January 2018 to January 2021. |
| KRAS Biomarkers profile evaluation at NSCLC diagnosis | Percentage of KRAS test performed along with result | Restrospective data capture from January 2018 to January 2021. |
| ASST degli Spedali Civili di Brescia | Not yet recruiting | Brescia | Italy |
|
| Gemelli Molise | Not yet recruiting | Campobasso | Italy |
|
| Humanitas Istituto Clinico Catanese | Not yet recruiting | Catania | Italy |
|
| Policlinico Rodolico | Not yet recruiting | Catania | Italy |
|
| AOU Careggi | Recruiting | Florence | Italy |
|
| IRCCS Policlinico S. Martino | Recruiting | Genova | Italy |
|
| AO Papardo | Not yet recruiting | Messina | Italy |
|
| IRCCS Ospedale San Raffaele | Recruiting | Milan | Italy |
|
| Istituto Clinico Humanitas | Recruiting | Milan | Italy |
|
| Istituto Nazionale dei Tumori - Fondazione IRCCS | Not yet recruiting | Milan | Italy |
|
| AOU dei Colli - Monaldi | Not yet recruiting | Naples | Italy |
|
| AOU Vanvitelli | Recruiting | Naples | Italy |
|
| A.O.U. Maggiore della Carità di Novara | Recruiting | Novara | Italy |
|
| IOV - Istituto Oncologico veneto - IRCCS | Not yet recruiting | Padova | Italy |
|
| AOUP Policlinico Giaccone | Not yet recruiting | Palermo | Italy |
|
| Azienda Ospedaliera Perugia - Ospedale S. Maria della MIsericordia | Not yet recruiting | Perugia | Italy |
|
| Azienda USL Toscana Centro - Ospedale san Jacopo | Recruiting | Pistoia | Italy |
|
| Centro di Riferimento Oncologico IRCCS | Not yet recruiting | Pordenone | Italy |
|
| Azienda Ospedaliera Regionale San Carlo di Potenza | Not yet recruiting | Potenza | Italy |
|
| AUSL Romagna Ospedale Santa Maria delle Croci Ravenna | Not yet recruiting | Ravenna | Italy |
|
| IRCCS AUSL Reggio Emilia | Not yet recruiting | Reggio Emilia | Italy |
|
| Fondazione Policlinico Universitario "A. Gemelli" | Not yet recruiting | Roma | Italy |
|
| ASST dei Sette Laghi | Not yet recruiting | Varese | Italy |
|
| AOUI Verona | Not yet recruiting | Verona | Italy |
|
| 27041452 | Background | 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. |
| 33209868 | Background | 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. |
| 30770291 | Background | 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. |
| 30982687 | Background | 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. |
| 26811519 | Background | 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. |
| 25601342 | Background | 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. |
| 27328310 | Background | 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. |
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| 20338627 | Background | 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. |
| 18506026 | Background | 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. |
| 28056112 | Background | 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. |
| 25870801 | Background | 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. |
| 20231678 | Background | 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. |
| 22124104 | Background | Scagliotti GV, Pastorino U, Vansteenkiste JF, Spaggiari L, Facciolo F, Orlowski TM, Maiorino L, Hetzel M, Leschinger M, Visseren-Grul C, Torri V. Randomized phase III study of surgery alone or surgery plus preoperative cisplatin and gemcitabine in stages IB to IIIA non-small-cell lung cancer. J Clin Oncol. 2012 Jan 10;30(2):172-8. doi: 10.1200/JCO.2010.33.7089. Epub 2011 Nov 28. |
| 20107424 | Background | Song WA, Zhou NK, Wang W, Chu XY, Liang CY, Tian XD, Guo JT, Liu X, Liu Y, Dai WM. Survival benefit of neoadjuvant chemotherapy in non-small cell lung cancer: an updated meta-analysis of 13 randomized control trials. J Thorac Oncol. 2010 Apr;5(4):510-6. doi: 10.1097/JTO.0b013e3181cd3345. |
| 20516435 | Background | Felip E, Rosell R, Maestre JA, Rodriguez-Paniagua JM, Moran T, Astudillo J, Alonso G, Borro JM, Gonzalez-Larriba JL, Torres A, Camps C, Guijarro R, Isla D, Aguilo R, Alberola V, Padilla J, Sanchez-Palencia A, Sanchez JJ, Hermosilla E, Massuti B; Spanish Lung Cancer Group. Preoperative chemotherapy plus surgery versus surgery plus adjuvant chemotherapy versus surgery alone in early-stage non-small-cell lung cancer. J Clin Oncol. 2010 Jul 1;28(19):3138-45. doi: 10.1200/JCO.2009.27.6204. Epub 2010 Jun 1. |
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| 17544497 | Background | Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, Hatton M, Hopwood P, Manegold C, Schramel F, Smit H, van Meerbeeck J, Nankivell M, Parmar M, Pugh C, Stephens R. Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review. Lancet. 2007 Jun 9;369(9577):1929-37. doi: 10.1016/S0140-6736(07)60714-4. |
| 9690404 | Background | Postoperative radiotherapy in non-small-cell lung cancer: systematic review and meta-analysis of individual patient data from nine randomised controlled trials. PORT Meta-analysis Trialists Group. Lancet. 1998 Jul 25;352(9124):257-63. |
| 18439766 | Background | Douillard JY, Rosell R, De Lena M, Riggi M, Hurteloup P, Mahe MA; Adjuvant Navelbine International Trialist Association. Impact of postoperative radiation therapy on survival in patients with complete resection and stage I, II, or IIIA non-small-cell lung cancer treated with adjuvant chemotherapy: the adjuvant Navelbine International Trialist Association (ANITA) Randomized Trial. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):695-701. doi: 10.1016/j.ijrobp.2008.01.044. Epub 2008 Apr 24. |
| 25384064 | Background | Mikell JL, Gillespie TW, Hall WA, Nickleach DC, Liu Y, Lipscomb J, Ramalingam SS, Rajpara RS, Force SD, Fernandez FG, Owonikoko TK, Pillai RN, Khuri FR, Curran WJ, Higgins KA. Postoperative radiotherapy is associated with better survival in non-small cell lung cancer with involved N2 lymph nodes: results of an analysis of the National Cancer Data Base. J Thorac Oncol. 2015 Mar;10(3):462-71. doi: 10.1097/JTO.0000000000000411. |
| 32955177 | Background | Wu YL, Tsuboi M, He J, John T, Grohe C, Majem M, Goldman JW, Laktionov K, Kim SW, Kato T, Vu HV, Lu S, Lee KY, Akewanlop C, Yu CJ, de Marinis F, Bonanno L, Domine M, Shepherd FA, Zeng L, Hodge R, Atasoy A, Rukazenkov Y, Herbst RS; ADAURA Investigators. Osimertinib in Resected EGFR-Mutated Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Oct 29;383(18):1711-1723. doi: 10.1056/NEJMoa2027071. Epub 2020 Sep 19. |
| 28885881 | Background | Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8. |
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| 29658848 | Background | Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16. |
| 32386568 | Background | Shu CA, Gainor JF, Awad MM, Chiuzan C, Grigg CM, Pabani A, Garofano RF, Stoopler MB, Cheng SK, White A, Lanuti M, D'Ovidio F, Bacchetta M, Sonett JR, Saqi A, Rizvi NA. Neoadjuvant atezolizumab and chemotherapy in patients with resectable non-small-cell lung cancer: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):786-795. doi: 10.1016/S1470-2045(20)30140-6. Epub 2020 May 7. |
| 32979984 | Background | Provencio M, Nadal E, Insa A, Garcia-Campelo MR, Casal-Rubio J, Domine M, Majem M, Rodriguez-Abreu D, Martinez-Marti A, De Castro Carpeno J, Cobo M, Lopez Vivanco G, Del Barco E, Bernabe Caro R, Vinolas N, Barneto Aranda I, Viteri S, Pereira E, Royuela A, Casarrubios M, Salas Anton C, Parra ER, Wistuba I, Calvo V, Laza-Briviesca R, Romero A, Massuti B, Cruz-Bermudez A. Neoadjuvant chemotherapy and nivolumab in resectable non-small-cell lung cancer (NADIM): an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1413-1422. doi: 10.1016/S1470-2045(20)30453-8. Epub 2020 Sep 24. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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