Advanced Non Small Cell Lung Cancer2012/52NCT02407327
Individualized Treatment of Patients With Advanced NSCLC: Potential Application for Circulating Tumor Cells (CTC) Molecular and Phenotypical Profiling
An observational study of Advanced Non Small Cell Lung Cancer, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial summary
The purpose of this study is to determine the percentage of CTC-positive patients and total CTC numbers in patients with advanced Non Small Cell Lung Cancer . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Non Small Cell Lung Cancer
- How many people
- 215 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2012to 1 Dec 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Age 18-80 years old, males or females;
- Patients with NSCLC confirmed by histopathology or cytology;
- Life expectancy > 6 months;
- Patients are voluntary to participate and sign the informed contents
Who cannot join
- Any condition which might hamper compliance to the schedule of assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trattamento Personalizzato Del Tumore NSCLC Avanzato: Potenziali Applicazioni Della Caratterizzazione Fenotipica e Molecolare Delle Cellule Tumorali Circolanti (CTC)
The purpose of this study is to determine the percentage of CTC-positive patients and total CTC numbers in patients with advanced Non Small Cell Lung Cancer .
Read the detailed description
The primary aim of the Project is to determine the percentage of CTC-positive patients and total CTC numbers in advanced NSCLC at baseline, before starting treatment.
To valuate CTC count modifications as an early predictor of response to treatment a prospective observational study will be conducted, consecutively enrolling 150 patients regardless of type or line of therapy, which will be reevaluated for disease status and CTC count depending on the type and schedule of treatment.
Furthermore, purified CTC will be obtained by automated platform and DNA sequencing will be performed to assess sensitizing mutations in advanced NSCLC patients. The EGFR mutations or EML4-ALK fusion gene detected in CTC will be compared with those reported for the tumor specimen using standard sequencing.
In parallel, the CTC count assay will be integrated with mAb targeting EGFR or EML4-ALK fusion gene, to test whether assaying the quote of EGFR-positive and ALK-positive CTC provides a more sensitive marker for rating pharmacodynamic effects in patients compared with total CTC counts.
Moreover, it was reported that NSCLC cells with EGFR mutations manifest activation of the PI3K (phosphatidylinositol 3-kinase)-AKT and MEK-ERK (extracellular signal-regulated kinase) signaling pathways under the control of EGFR, and exposure of such cells to EGFR-TKIs blocks signaling by both pathways and induces apoptosis 13. To evaluate whether live vs. apoptotic CTC changes under treatment may be used as predictor of tumor response, M30-positive CTC will be quantified as previously 8.
Data obtained with the CTC assay will be correlated with common prognostic factors.
- Conditions
- Advanced Non Small Cell Lung Cancer
- Keywords
- Circulating tumour cells in Advanced Non Small Cell Lung Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of CTC count during treatment and comparison with CT and PET
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study start1 Dec 2012
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Advanced Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407327
- Sponsor's protocol ID
- GR-2010-2303193
- Acronym
- 2012/52
- Status last verified
- Oct 2023
- First submitted
- 30 Mar 2015
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.
PubMed 19692680Mitsudomi 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 20022809Amadori A, Rossi E, Zamarchi R, Carli P, Pastorelli D, Jirillo A. Circulating and disseminated tumor cells in the clinical management of breast cancer patients: unanswered questions. Oncology. 2009;76(6):375-86. doi: 10.1159/000215581. Epub 2009 Apr 30.
PubMed 19407470Meng S, Tripathy D, Shete S, Ashfaq R, Haley B, Perkins S, Beitsch P, Khan A, Euhus D, Osborne C, Frenkel E, Hoover S, Leitch M, Clifford E, Vitetta E, Morrison L, Herlyn D, Terstappen LW, Fleming T, Fehm T, Tucker T, Lane N, Wang J, Uhr J. HER-2 gene amplification can be acquired as breast cancer progresses. Proc Natl Acad Sci U S A. 2004 Jun 22;101(25):9393-8. doi: 10.1073/pnas.0402993101. Epub 2004 Jun 11.
PubMed 15194824de Bono JS, Attard G, Adjei A, Pollak MN, Fong PC, Haluska P, Roberts L, Melvin C, Repollet M, Chianese D, Connely M, Terstappen LW, Gualberto A. Potential applications for circulating tumor cells expressing the insulin-like growth factor-I receptor. Clin Cancer Res. 2007 Jun 15;13(12):3611-6. doi: 10.1158/1078-0432.CCR-07-0268.
PubMed 17575225Wang LH, Pfister TD, Parchment RE, Kummar S, Rubinstein L, Evrard YA, Gutierrez ME, Murgo AJ, Tomaszewski JE, Doroshow JH, Kinders RJ. Monitoring drug-induced gammaH2AX as a pharmacodynamic biomarker in individual circulating tumor cells. Clin Cancer Res. 2010 Feb 1;16(3):1073-84. doi: 10.1158/1078-0432.CCR-09-2799. Epub 2010 Jan 26.
PubMed 20103672Maheswaran S, Sequist LV, Nagrath S, Ulkus L, Brannigan B, Collura CV, Inserra E, Diederichs S, Iafrate AJ, Bell DW, Digumarthy S, Muzikansky A, Irimia D, Settleman J, Tompkins RG, Lynch TJ, Toner M, Haber DA. Detection of mutations in EGFR in circulating lung-cancer cells. N Engl J Med. 2008 Jul 24;359(4):366-77. doi: 10.1056/NEJMoa0800668. Epub 2008 Jul 2.
PubMed 18596266Hofman V, Ilie MI, Long E, Selva E, Bonnetaud C, Molina T, Venissac N, Mouroux J, Vielh P, Hofman P. Detection of circulating tumor cells as a prognostic factor in patients undergoing radical surgery for non-small-cell lung carcinoma: comparison of the efficacy of the CellSearch Assay and the isolation by size of epithelial tumor cell method. Int J Cancer. 2011 Oct 1;129(7):1651-60. doi: 10.1002/ijc.25819. Epub 2011 Mar 11.
PubMed 21128227Krebs MG, Sloane R, Priest L, Lancashire L, Hou JM, Greystoke A, Ward TH, Ferraldeschi R, Hughes A, Clack G, Ranson M, Dive C, Blackhall FH. Evaluation and prognostic significance of circulating tumor cells in patients with non-small-cell lung cancer. J Clin Oncol. 2011 Apr 20;29(12):1556-63. doi: 10.1200/JCO.2010.28.7045. Epub 2011 Mar 21.
PubMed 21422424Sakairi Y, Nakajima T, Yasufuku K, Ikebe D, Kageyama H, Soda M, Takeuchi K, Itami M, Iizasa T, Yoshino I, Mano H, Kimura H. EML4-ALK fusion gene assessment using metastatic lymph node samples obtained by endobronchial ultrasound-guided transbronchial needle aspiration. Clin Cancer Res. 2010 Oct 15;16(20):4938-45. doi: 10.1158/1078-0432.CCR-10-0099. Epub 2010 Oct 5.
PubMed 20926401Tracy S, Mukohara T, Hansen M, Meyerson M, Johnson BE, Janne PA. Gefitinib induces apoptosis in the EGFRL858R non-small-cell lung cancer cell line H3255. Cancer Res. 2004 Oct 15;64(20):7241-4. doi: 10.1158/0008-5472.CAN-04-1905.
PubMed 15492241Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
PubMed 15317891Pirker R, Herth FJ, Kerr KM, Filipits M, Taron M, Gandara D, Hirsch FR, Grunenwald D, Popper H, Smit E, Dietel M, Marchetti A, Manegold C, Schirmacher P, Thomas M, Rosell R, Cappuzzo F, Stahel R; European EGFR Workshop Group. Consensus for EGFR mutation testing in non-small cell lung cancer: results from a European workshop. J Thorac Oncol. 2010 Oct;5(10):1706-13. doi: 10.1097/JTO.0b013e3181f1c8de.
PubMed 20871269Schwarzenbach H, Chun FK, Isbarn H, Huland H, Pantel K. Genomic profiling of cell-free DNA in blood and bone marrow of prostate cancer patients. J Cancer Res Clin Oncol. 2011 May;137(5):811-9. doi: 10.1007/s00432-010-0941-5. Epub 2010 Aug 4.
PubMed 20683729Amadori A, Zamarchi R, De Silvestro G, Forza G, Cavatton G, Danieli GA, Clementi M, Chieco-Bianchi L. Genetic control of the CD4/CD8 T-cell ratio in humans. Nat Med. 1995 Dec;1(12):1279-83. doi: 10.1038/nm1295-1279.
PubMed 7489409
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trattamento Personalizzato Del Tumore NSCLC Avanzato: Potenziali Applicazioni Della Caratterizzazione Fenotipica e Molecolare Delle Cellule Tumorali Circolanti (CTC)
- ClinicalTrials.gov ID
- NCT02407327
- Acronym / sponsor ID
- 2012/52 / GR-2010-2303193
- Conditions
- Advanced Non Small Cell Lung Cancer
- Keywords
- Circulating tumour cells in Advanced Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the percentage of CTC-positive patients and total CTC numbers in patients with advanced Non Small Cell Lung Cancer .
Detailed description
The primary aim of the Project is to determine the percentage of CTC-positive patients and total CTC numbers in advanced NSCLC at baseline, before starting treatment.
To valuate CTC count modifications as an early predictor of response to treatment a prospective observational study will be conducted, consecutively enrolling 150 patients regardless of type or line of therapy, which will be reevaluated for disease status and CTC count depending on the type and schedule of treatment.
Furthermore, purified CTC will be obtained by automated platform and DNA sequencing will be performed to assess sensitizing mutations in advanced NSCLC patients. The EGFR mutations or EML4-ALK fusion gene detected in CTC will be compared with those reported for the tumor specimen using standard sequencing.
In parallel, the CTC count assay will be integrated with mAb targeting EGFR or EML4-ALK fusion gene, to test whether assaying the quote of EGFR-positive and ALK-positive CTC provides a more sensitive marker for rating pharmacodynamic effects in patients compared with total CTC counts.
Moreover, it was reported that NSCLC cells with EGFR mutations manifest activation of the PI3K (phosphatidylinositol 3-kinase)-AKT and MEK-ERK (extracellular signal-regulated kinase) signaling pathways under the control of EGFR, and exposure of such cells to EGFR-TKIs blocks signaling by both pathways and induces apoptosis 13. To evaluate whether live vs. apoptotic CTC changes under treatment may be used as predictor of tumor response, M30-positive CTC will be quantified as previously 8.
Data obtained with the CTC assay will be correlated with common prognostic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Age 18-80 years old, males or females;
- Patients with NSCLC confirmed by histopathology or cytology;
- Life expectancy > 6 months;
- Patients are voluntary to participate and sign the informed contents
Key exclusion criteria (1 listed)
- Any condition which might hamper compliance to the schedule of assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of CTC count during treatment and comparison with CT and PET
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Background: PubMed 19692680Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.
- Background: PubMed 20022809Mitsudomi 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.
- Background: PubMed 19407470Amadori A, Rossi E, Zamarchi R, Carli P, Pastorelli D, Jirillo A. Circulating and disseminated tumor cells in the clinical management of breast cancer patients: unanswered questions. Oncology. 2009;76(6):375-86. doi: 10.1159/000215581. Epub 2009 Apr 30.
- Background: PubMed 15194824Meng S, Tripathy D, Shete S, Ashfaq R, Haley B, Perkins S, Beitsch P, Khan A, Euhus D, Osborne C, Frenkel E, Hoover S, Leitch M, Clifford E, Vitetta E, Morrison L, Herlyn D, Terstappen LW, Fleming T, Fehm T, Tucker T, Lane N, Wang J, Uhr J. HER-2 gene amplification can be acquired as breast cancer progresses. Proc Natl Acad Sci U S A. 2004 Jun 22;101(25):9393-8. doi: 10.1073/pnas.0402993101. Epub 2004 Jun 11.
- Background: PubMed 17575225de Bono JS, Attard G, Adjei A, Pollak MN, Fong PC, Haluska P, Roberts L, Melvin C, Repollet M, Chianese D, Connely M, Terstappen LW, Gualberto A. Potential applications for circulating tumor cells expressing the insulin-like growth factor-I receptor. Clin Cancer Res. 2007 Jun 15;13(12):3611-6. doi: 10.1158/1078-0432.CCR-07-0268.
- Background: PubMed 20103672Wang LH, Pfister TD, Parchment RE, Kummar S, Rubinstein L, Evrard YA, Gutierrez ME, Murgo AJ, Tomaszewski JE, Doroshow JH, Kinders RJ. Monitoring drug-induced gammaH2AX as a pharmacodynamic biomarker in individual circulating tumor cells. Clin Cancer Res. 2010 Feb 1;16(3):1073-84. doi: 10.1158/1078-0432.CCR-09-2799. Epub 2010 Jan 26.
- Background: PubMed 18596266Maheswaran S, Sequist LV, Nagrath S, Ulkus L, Brannigan B, Collura CV, Inserra E, Diederichs S, Iafrate AJ, Bell DW, Digumarthy S, Muzikansky A, Irimia D, Settleman J, Tompkins RG, Lynch TJ, Toner M, Haber DA. Detection of mutations in EGFR in circulating lung-cancer cells. N Engl J Med. 2008 Jul 24;359(4):366-77. doi: 10.1056/NEJMoa0800668. Epub 2008 Jul 2.
- Background: PubMed 21128227Hofman V, Ilie MI, Long E, Selva E, Bonnetaud C, Molina T, Venissac N, Mouroux J, Vielh P, Hofman P. Detection of circulating tumor cells as a prognostic factor in patients undergoing radical surgery for non-small-cell lung carcinoma: comparison of the efficacy of the CellSearch Assay and the isolation by size of epithelial tumor cell method. Int J Cancer. 2011 Oct 1;129(7):1651-60. doi: 10.1002/ijc.25819. Epub 2011 Mar 11.
- Background: PubMed 21422424Krebs MG, Sloane R, Priest L, Lancashire L, Hou JM, Greystoke A, Ward TH, Ferraldeschi R, Hughes A, Clack G, Ranson M, Dive C, Blackhall FH. Evaluation and prognostic significance of circulating tumor cells in patients with non-small-cell lung cancer. J Clin Oncol. 2011 Apr 20;29(12):1556-63. doi: 10.1200/JCO.2010.28.7045. Epub 2011 Mar 21.
- Background: PubMed 20926401Sakairi Y, Nakajima T, Yasufuku K, Ikebe D, Kageyama H, Soda M, Takeuchi K, Itami M, Iizasa T, Yoshino I, Mano H, Kimura H. EML4-ALK fusion gene assessment using metastatic lymph node samples obtained by endobronchial ultrasound-guided transbronchial needle aspiration. Clin Cancer Res. 2010 Oct 15;16(20):4938-45. doi: 10.1158/1078-0432.CCR-10-0099. Epub 2010 Oct 5.
- Background: PubMed 15492241Tracy S, Mukohara T, Hansen M, Meyerson M, Johnson BE, Janne PA. Gefitinib induces apoptosis in the EGFRL858R non-small-cell lung cancer cell line H3255. Cancer Res. 2004 Oct 15;64(20):7241-4. doi: 10.1158/0008-5472.CAN-04-1905.
- Background: PubMed 15317891Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Non Small Cell Lung Cancer, run by Istituto Oncologico Veneto IRCCS at 1 site 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 4 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Change of CTC count during treatment and comparison with CT and PET (time frame: 36 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 NCT02407327, which also lists 20 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 1 Nov 2023.