ClinicalTrials.gg
RecruitingNCT06467383Key-EarlyUpdated Jan 14, 2025

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

An observational study in Non-small Cell Lung Cancer, NSCLC and NSCLC, Stage III, sponsored by MSD Italia S.r.l.. Recruiting at 25 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by MSD Italia S.r.l. (part of Merck & Co., Inc) · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Non-small Cell Lung Cancer
  • NSCLC
  • NSCLC, Stage III
  • NSCLC, Stage I

Keywords

  • NSCLC early stage
  • NSCLC locally advanced
  • retrospective observational study
  • Real-World Evidence
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 600 is above the median of 164 across 974 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

MSD Italia S.r.l. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. Adult patients (aged ≥ 18 years) at the moment of diagnosis
  3. 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.

Exclusion criteria

Exclusion Criteria:

  1. Patients without availability of medical charts or information required
  2. Enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Restrospective data capture from January 2018 to January 2021.

Secondary outcomes

  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

    Time frame: Restrospective data capture from January 2018 to January 2021.

Other outcomes

  1. Biomarkers profile evaluation at NSCLC diagnosis

    Percentage of PD-L1, EGFR/ALK, KRAS test performed along with results

    Time frame: Restrospective data capture from January 2018 to January 2021.

  2. PD-L1 Biomarker profile evaluation at NSCLC diagnosis

    Percentage of PD-L1 test performed along with results

    Time frame: Restrospective data capture from January 2018 to January 2021.

  3. EGFR/ALK Biomarkers profile evaluation at NSCLC diagnosis

    Percentage of EGFR/ALK test performed along with results

    Time frame: Restrospective data capture from January 2018 to January 2021.

  4. KRAS Biomarkers profile evaluation at NSCLC diagnosis

    Percentage of KRAS test performed along with result

    Time frame: Restrospective data capture from January 2018 to January 2021.

07

Study locations

7 of 25 sites recruiting
  • IRCCS Casa di sollievo dalla sofferenza
    San Giovanni Rotondo, FG, Italy
    • Evaristo Maiello, MD · Contact
    Not yet recruiting
  • ASST degli Spedali Civili di Brescia
    Brescia, Italy
    • Salvatore Grisanti, MD · Contact
    Not yet recruiting
  • Gemelli Molise
    Campobasso, Italy
    • Andrea Mancuso Petricca, MD · Contact
    Not yet recruiting
  • Humanitas Istituto Clinico Catanese
    Catania, Italy
    • Michele Caruso, MD · Contact
    Not yet recruiting
  • Policlinico Rodolico
    Catania, Italy
    • Hector Soto Parra, MD · Contact
    Not yet recruiting
  • AOU Careggi
    Florence, Italy
    • Lorenzo Antonuzzo, MD · Contact
    Recruiting
  • IRCCS Policlinico S. Martino
    Genova, Italy
    • Carlo Genova, MD · Contact
    Recruiting
  • AO Papardo
    Messina, Italy
    • Alessandro Russo, MD · Contact
    Not yet recruiting
  • IRCCS Ospedale San Raffaele
    Milan, Italy
    • Giulia Veronesi, MD · Contact
    Recruiting
  • Istituto Clinico Humanitas
    Milan, Italy
    • Sabrina Rossi, MD · Contact
    Recruiting
  • Istituto Nazionale dei Tumori - Fondazione IRCCS
    Milan, Italy
    • Giuseppe Lo Russo, MD · Contact
    Not yet recruiting
  • AOU dei Colli - Monaldi
    Naples, Italy
    • Danilo Rocco, MD · Contact
    Not yet recruiting
  • AOU Vanvitelli
    Naples, Italy
    • Floriana Morgillo, MD · Contact
    Recruiting
  • A.O.U. Maggiore della Carità di Novara
    Novara, Italy
    • Gloria Borra, MD · Contact
    Recruiting
  • IOV - Istituto Oncologico veneto - IRCCS
    Padova, Italy
    • Laura Bonanno, MD · Contact
    Not yet recruiting
  • AOUP Policlinico Giaccone
    Palermo, Italy
    • Antonio Russo, MD · Contact
    Not yet recruiting
  • Azienda Ospedaliera Perugia - Ospedale S. Maria della MIsericordia
    Perugia, Italy
    • Maria Francesca Currà · Contact
    Not yet recruiting
  • Azienda USL Toscana Centro - Ospedale san Jacopo
    Pistoia, Italy
    • Mauro Iannopollo, MD · Contact
    Recruiting
  • Centro di Riferimento Oncologico IRCCS
    Pordenone, Italy
    • Brigida Stanzione, MD · Contact
    Not yet recruiting
  • Azienda Ospedaliera Regionale San Carlo di Potenza
    Potenza, Italy
    • Domenico Bilancia, MD · Contact
    Not yet recruiting
  • AUSL Romagna Ospedale Santa Maria delle Croci Ravenna
    Ravenna, Italy
    • Chiara Bennati, MD · Contact
    Not yet recruiting
  • IRCCS AUSL Reggio Emilia
    Reggio Emilia, Italy
    • Francesca Zanelli, MD · Contact
    Not yet recruiting
  • Fondazione Policlinico Universitario "A. Gemelli"
    Roma, Italy
    • Emilio Bria, MD · Contact
    Not yet recruiting
  • ASST dei Sette Laghi
    Varese, Italy
    • Francesco Grossi, MD · Contact
    Not yet recruiting
  • AOUI Verona
    Verona, Italy
    • Sara Pilotto, MD · Contact
    Not yet recruiting
08

References and documents

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 ↗
  • 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. PubMed 22124104 ↗
  • 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. PubMed 20107424 ↗
  • 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. PubMed 20516435 ↗
  • NSCLC Meta-analysis Collaborative Group. Preoperative chemotherapy for non-small-cell lung cancer: a systematic review and meta-analysis of individual participant data. Lancet. 2014 May 3;383(9928):1561-71. doi: 10.1016/S0140-6736(13)62159-5. Epub 2014 Feb 25. PubMed 24576776 ↗
  • 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. PubMed 17544497 ↗
  • 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. PubMed 9690404 ↗
  • 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. PubMed 18439766 ↗
  • 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. PubMed 25384064 ↗
  • 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. PubMed 32955177 ↗
  • 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. PubMed 28885881 ↗
  • Gray JE, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, Cho BC, Planchard D, Paz-Ares L, Faivre-Finn C, Vansteenkiste JF, Spigel DR, Wadsworth C, Taboada M, Dennis PA, Ozguroglu M, Antonia SJ. Three-Year Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC-Update from PACIFIC. J Thorac Oncol. 2020 Feb;15(2):288-293. doi: 10.1016/j.jtho.2019.10.002. Epub 2019 Oct 14. PubMed 31622733 ↗
  • 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. PubMed 29658848 ↗
  • 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. PubMed 32386568 ↗
  • 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. PubMed 32979984 ↗

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06467383
Lead sponsor
MSD Italia S.r.l.
Collaborators
YGHEA, CRO Division of Ecol Studio spa
Responsible party
Sponsor
First posted
Jun 21, 2024
Start date
Jun 25, 2024
Primary completion
Jun 24, 2025 (estimated)
Completion
Jun 24, 2025 (estimated)
Last update
Jan 14, 2025

Study contacts

Daniele Righi, PM
Contact
d.righi@yghea.it
+39 051 5878211
Giada Iuliano, MD
study chair · MSD Italia srl

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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