Lung NeoplasmsNIRVANANCT03220230
Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.
An observational study of Lung Neoplasms, run by Pfizer at 37 sites in 3 countries.
Trial summary
This is a non-interventional multi-center with investigational sites in Chile and Brasil diagnostic study to validate novel diagnostic technologies, such as Next Generation Sequencing (NGS) from both tissue and blood compared to the current gold standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- How many people
- 4,240 participants
- Where
- 37 sitesin 3 countries
- Study dates
- 6 Jul 2015to 30 Oct 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Lung cancer patients.
Who may be able to join
- Female or male, 18 years of age or older.
- Patients with histologically or cytological proven diagnosis of NSCLC, pathologically identified as adenocarcinoma.
- Patient naïve in lung cancer treatment
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the study prior to enrollment.
- Patients must give consent to the research use of their archived or tumor FFPE tissue, and if available, 2 blood tubes.
Who cannot join
- Prior chemotherapy treatment.
Trial locations and contacts
37 sites in 3 countries.
37 sites in 3 countries
Brazil19 sites
Instituto Goiano de Oncología e Hematologia
Aparecida de Goiana, Goiás, 74915-520
Fundaçao Pio XII, Hospital do Cancer de Barretos
Barretos
Hospital Luxemburgo
Belo Horizonte, Minas Gerais, 30380-472
Hospital Felicio Rocho
Belo Horizonte /MG, Minas Gerais, 30110-934
Liga Paranaense de Combate ao Cancer Hospital Erasto Gaetner
Curtiba-PR
Centro Regional Integrado de Oncologia
Fortaleza, Caera, 60336-550
Instituto de Cancer de Londrina
Londrina, Paraná
Hospital Sao Lucas da PUCRS
Porto Alegre
Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita
Porto Alegre
Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
Recife
Instituto COI de Pesquisa Educacao e Gestao
Rio de Janeiro, 22793-080
Hospital Da Bahia
Salvador, 41820-011
Hospital Santa Izabel
Salvador
Nucleo de Oncologia da Bahia
Salvador
Centro de Pesquisa da Universidade Federal de Sao Paulo - UNIFESP
São Paulo, VILA Clementino, 04024-002
Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda
São Paulo, 18035-300
A.C. Camargo Cancer Center
São Paulo
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São Paulo
Hospital Israelita Albert Einstein
São Paulo/SP, 05651-901
Chile9 sites
Hospital Base de Arica
Arica
Hosp Regional de Concepcion
Concepción
Universidad Católica del Norte
Coquimbo
Hospital Clinico Universidad de Chile, Seccion de Oncologia
Independencia, Santiago, RM, 8380456
Hospital Base de Puerto Montt
Port Montt, Los Lagos Region, 5506667
Centro Internacional de Estudios Clinicos
Santiago, RM, 8420383
Instituto Nacional Del Torax
Santiago
Instituto Clinico Oncologico del Sur (ICOS)
Temuco, Ranco, 4810469
Hospital Base de Valdivia
Valdivia, Los Lagos Region, 5090145
Peru9 sites
Hospital Carlos Alberto Seguin Escobedo
Arequipa
Hospital Nacional Hipolito Unanue
El Agustino
Clinica San Felipe
Lima, 11
Hospital Central de la Fuerza Aerea Peruana
Lima, 18
Instituto Nacional de Enfermedales Neoplasicas (INEN)
Lima, 34
Oncosalud
Lima, 41
Unidad de Investigacion de la Clinica Internacional - Sede San Borja
Lima, 41
Clínica Quirurgica Santa Maria
Lima
Centro de Investigación Clínica Trujillo E.I.R.L.
Trujillo, 13001
About this study
Official title: NON INTERVENTIONAL MULTICENTER STUDY, FOR THE VALIDATION OF MOLECULAR DIAGNOSTIC TECHNOLOGIES IN SUBJECTS WITH NON SMALL CELL LUNG CANCER (NSCLC) PROTOCOL N° X9001083
This is a non-interventional multi-center with investigational sites in Chile and Brasil diagnostic study to validate novel diagnostic technologies, such as Next Generation Sequencing (NGS) from both tissue and blood compared to the current gold standard. As a non-interventional study, patients will receive the treatment indicated by their doctor independently of their participation on this study.
Many cancer cells look the same under the microscope. But as these cells are studied at the molecular level, some genetic alterations or defects that are more common to certain types of cancer are identified. In some cases, these defects are what make the cells grow and multiply abnormally.
Read more
Biomarkers are the molecular fingerprints of these genetic defects. By testing a sample of your tumor for biomarkers, doctors can learn if your cancer has one of these defects, and that may point to a specific treatment choice.
One of the genetic biomarkers that are believed to cause some cancers to grow is the ALK fusion gene. About 3% to 5% of people with NSCLC may test positive for ALK. ROS1 is a receptor found in 1 to 2% of people with this type of cancer.
The present study is designed to advance the molecular testing methodologies to identify ALK+ and ROS1+ NSCLC patients.
A positive correlation with these new technologies will mean an efficient, more accurate diagnostic test, which could impact a greater number of cancer patients around world.
Read the detailed description
- Lung Cancer Non-small cell lung cancer (NSCLC) is a common cause of cancer mortality throughout the world. In 2007, there were 1.5 million new lung cancer cases diagnosed worldwide, including around 733,100 cases in the South American Region.6
Approximately 85% of lung cancer is histologically defined as non small cell and the remaining 14% as small cell. The majority of patients with NSCLC present with inoperable locally advanced (Stage IIIB) or metastatic (Stage IV) disease for which no curative treatment is yet available. In newly diagnosed patients with good performance status, platinum based doublet-combination chemotherapies are associated with a median overall survival (OS) of 7.4 to 9.9 months. 7, 8, 9, 10, 11, 12 Therefore, newer agents with novel mechanisms of action are still desperately needed for this serious life-threatening disease. 15,16
The rapid and efficient identification of key driver genes in non-small-cell lung cancer (NSCLC) is becoming increasingly important.17 Clinical screening efforts have revealed that the most common mutations in lung cancer specimens involve EGFR and KRAS, along with 10 other genes that show a prevalence of mutation in 5% or less of tumors. The ALK gene is rearranged in around 3%-5% of patients with NSCLC and has been the focus of intense basic and clinical research, suggesting that the frequency of the gene rearrangement is similar in Asian and Western patients.
ROS1 is a receptor tyrosine kinase of the insulin receptor family. Chromosomal rearrangements involving the ROS1 gene were originally described in glioblastomas, where ROS1 (chromosome 6q22) is fused to the FIG gene (chromosome 6q22 immediately adjacent to ROS1), 16 and have been shown to be transforming in transgenic mice.17 More recently, ROS1 fusions were identified as potential driver mutations in an NSCLC cell line (HCC78; SLC34A2-ROS1) and an NSCLC patient sample (CD74-ROS1). 18 These fusions led to constitutive kinase activity and were associated with sensitivity in vitro and in vivo to crizotinib. As of December 2013, 16 different variants have been found.16, 17, 18
The present study is designed to advance the molecular testing methodologies to identify ALK+ and ROS1+ NSCLC patients. Advanced next generation sequencing screening methodologies will be used to identify NSCLC patients whose tumors contain a ROS1 gene inversion or translocation or an ALK translocation.
A parallel test for ALK+ by either the Abbott ALK FISH test or the Ventana ALK IHC test is necessary to validate the NGS test in all samples. A parallel test for ROS1+ by either the Kreatech FISH test or the D4D6 ROS1 IHC test may be necessary to validate the NGS test in all samples.
- Conditions
- Lung Neoplasms
- Keywords
- Next generation sequencing, Lung cancer, target therapies
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker
ALK status was measured by NGS- Oncomine focus assay (OFA) and Immuno histo chemistry (IHC) Ventana. Ventana -ALK and NGS-OFA were the assay procedures performed for ALK. The corresponding analysis of a specimen had 2 possible test results including ALK positive and ALK negative. True positives (tp) were defined as NGS-OFA and Ventana positive results, whereas false negatives (fn) were defined as NGS-OFA negative results and IHC-Ventana positive results. False positives (fp) were defined as NGS-OFA positive results and IHC-Ventana negative results. True negatives (tn) were defined as NGS-OFA and IHC Ventana negative results.
Measured: 40 months
Percentage of Concordance (Agreement) Between Ventana and NGS ALK Result
In this outcome measure, index of concordance with accuracy, sensitivity, specificity, positive predictive value and negative predictive value were measured. Accuracy (Acc): [tp+tn]/[tp+fp+fn+tn] *100; Sensitivity (Ss): tp/[tp+fn] *100; Specificity (Sp): tn/[fp+tn] *100; Positive Predictive Value (PPV): tp/[tp+fp] *100; Negative Predictive Value (NPV): tn/[fn+tn] *100.
Measured: 40 months
Secondary outcomes (5)
Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker by Type of Participants
Participants were categorized on the basis of prospective and retrospective. Prospective participants were those participants whose samples were taken after the informed consent. Retrospective participants were those participants whose samples were taken before the date of signature of the informed consent.
Measured: 40 months
Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking (Tobacco Use) History
The categories of smoker (tobacco use) were as follows: Never Smoker: No smoking exposure, Current Smoker: Currently uses tobacco in either cigarette, cigar or similar method (tobacco chewers excluded), Former Smoker: Participant at one time smoked but then later quit. Smoking status unknown: Participant whose smoking status is unknown.
Measured: 40 months
Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Stage and Classification of Biopsy
Stage was defined at time of initial diagnosis of NSCLC and participants were staged according to the guidelines set by the NCCN version 7.2015. Participant's stage was categorized as: stage 0, stage IA, stage IB, stage IIA, stage IIB, stage IIIA, stage IIIB, and stage IV. Biopsy NSCLC class was categorized as adenocarcinoma, neuroendocrine tumors, other known type of NSCLC and squamous cell carcinoma.
Measured: 40 months
Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Location
Locations were categorized as lungs, pleura, node mediastinal and others.
Measured: 40 months
Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender and Age
In this outcome measure, participants were categorized according to their gender (female/male) and different age ranges (18-30 / 31-40 / 41-60 / 60 and above).
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start6 Jul 2015
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 4,240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, PfizerRicardo Armisen, MD, PhD, Study chair, CEMP Pfizer Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220230
- Sponsor's protocol ID
- X9001083
- Other IDs
- NIRVANA
- Acronym
- NIRVANA
- Status last verified
- Oct 2019
- First submitted
- 5 Jul 2017
- Last updated
- 8 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NON INTERVENTIONAL MULTICENTER STUDY, FOR THE VALIDATION OF MOLECULAR DIAGNOSTIC TECHNOLOGIES IN SUBJECTS WITH NON SMALL CELL LUNG CANCER (NSCLC) PROTOCOL N° X9001083
- ClinicalTrials.gov ID
- NCT03220230
- Acronym / sponsor ID
- NIRVANA / X9001083
- Conditions
- Lung Neoplasms
- Keywords
- Next generation sequencing, Lung cancer, target therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,240 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Posted 8 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-interventional multi-center with investigational sites in Chile and Brasil diagnostic study to validate novel diagnostic technologies, such as Next Generation Sequencing (NGS) from both tissue and blood compared to the current gold standard. As a non-interventional study, patients will receive the treatment indicated by their doctor independently of their participation on this study.
Many cancer cells look the same under the microscope. But as these cells are studied at the molecular level, some genetic alterations or defects that are more common to certain types of cancer are identified. In some cases, these defects are what make the cells grow and multiply abnormally.
Biomarkers are the molecular fingerprints of these genetic defects. By testing a sample of your tumor for biomarkers, doctors can learn if your cancer has one of these defects, and that may point to a specific treatment choice.
One of the genetic biomarkers that are believed to cause some cancers to grow is the ALK fusion gene. About 3% to 5% of people with NSCLC may test positive for ALK. ROS1 is a receptor found in 1 to 2% of people with this type of cancer.
The present study is designed to advance the molecular testing methodologies to identify ALK+ and ROS1+ NSCLC patients.
A positive correlation with these new technologies will mean an efficient, more accurate diagnostic test, which could impact a greater number of cancer patients around world.
Detailed description
- Lung Cancer Non-small cell lung cancer (NSCLC) is a common cause of cancer mortality throughout the world. In 2007, there were 1.5 million new lung cancer cases diagnosed worldwide, including around 733,100 cases in the South American Region.6
Approximately 85% of lung cancer is histologically defined as non small cell and the remaining 14% as small cell. The majority of patients with NSCLC present with inoperable locally advanced (Stage IIIB) or metastatic (Stage IV) disease for which no curative treatment is yet available. In newly diagnosed patients with good performance status, platinum based doublet-combination chemotherapies are associated with a median overall survival (OS) of 7.4 to 9.9 months. 7, 8, 9, 10, 11, 12 Therefore, newer agents with novel mechanisms of action are still desperately needed for this serious life-threatening disease. 15,16
The rapid and efficient identification of key driver genes in non-small-cell lung cancer (NSCLC) is becoming increasingly important.17 Clinical screening efforts have revealed that the most common mutations in lung cancer specimens involve EGFR and KRAS, along with 10 other genes that show a prevalence of mutation in 5% or less of tumors. The ALK gene is rearranged in around 3%-5% of patients with NSCLC and has been the focus of intense basic and clinical research, suggesting that the frequency of the gene rearrangement is similar in Asian and Western patients.
ROS1 is a receptor tyrosine kinase of the insulin receptor family. Chromosomal rearrangements involving the ROS1 gene were originally described in glioblastomas, where ROS1 (chromosome 6q22) is fused to the FIG gene (chromosome 6q22 immediately adjacent to ROS1), 16 and have been shown to be transforming in transgenic mice.17 More recently, ROS1 fusions were identified as potential driver mutations in an NSCLC cell line (HCC78; SLC34A2-ROS1) and an NSCLC patient sample (CD74-ROS1). 18 These fusions led to constitutive kinase activity and were associated with sensitivity in vitro and in vivo to crizotinib. As of December 2013, 16 different variants have been found.16, 17, 18
The present study is designed to advance the molecular testing methodologies to identify ALK+ and ROS1+ NSCLC patients. Advanced next generation sequencing screening methodologies will be used to identify NSCLC patients whose tumors contain a ROS1 gene inversion or translocation or an ALK translocation.
A parallel test for ALK+ by either the Abbott ALK FISH test or the Ventana ALK IHC test is necessary to validate the NGS test in all samples. A parallel test for ROS1+ by either the Kreatech FISH test or the D4D6 ROS1 IHC test may be necessary to validate the NGS test in all samples.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung cancer patients.
Key inclusion criteria (5 listed)
- Female or male, 18 years of age or older.
- Patients with histologically or cytological proven diagnosis of NSCLC, pathologically identified as adenocarcinoma.
- Patient naïve in lung cancer treatment
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the study prior to enrollment.
- Patients must give consent to the research use of their archived or tumor FFPE tissue, and if available, 2 blood tubes.
Key exclusion criteria (1 listed)
- Prior chemotherapy treatment.
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
Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker
Time frame: 40 months
ALK status was measured by NGS- Oncomine focus assay (OFA) and Immuno histo chemistry (IHC) Ventana. Ventana -ALK and NGS-OFA were the assay procedures performed for ALK. The corresponding analysis of a specimen had 2 possible test results including ALK positive and ALK negative. True positives (tp) were defined as NGS-OFA and Ventana positive results, whereas false negatives (fn) were defined as NGS-OFA negative results and IHC-Ventana positive results. False positives (fp) were defined as NGS-OFA positive results and IHC-Ventana negative results. True negatives (tn) were defined as NGS-OFA and IHC Ventana negative results.
Percentage of Concordance (Agreement) Between Ventana and NGS ALK Result
Time frame: 40 months
In this outcome measure, index of concordance with accuracy, sensitivity, specificity, positive predictive value and negative predictive value were measured. Accuracy (Acc): [tp+tn]/[tp+fp+fn+tn] *100; Sensitivity (Ss): tp/[tp+fn] *100; Specificity (Sp): tn/[fp+tn] *100; Positive Predictive Value (PPV): tp/[tp+fp] *100; Negative Predictive Value (NPV): tn/[fn+tn] *100.
5 secondary outcomes
Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker by Type of Participants
Time frame: 40 months
Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Smoking (Tobacco Use) History
Time frame: 40 months
Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Stage and Classification of Biopsy
Time frame: 40 months
Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Location
Time frame: 40 months
Number of Participants With Association of Anaplastic Lymphoma Kinase (ALK) Rearrangement by Gender and Age
Time frame: 40 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
Ricardo Armisen, MD, PhD study chair
CEMP Pfizer Chile
37 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasms, run by Pfizer at 37 sites in 3 countries.
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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Brazil, Chile, Peru. 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?
Yes. Results are posted in the registry (first posted 8 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Prevalence of Anaplastic Lymphoma Kinase (ALK) Biomarker (time frame: 40 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2019.