Non-small Cell Lung CancerNCT03156868
Analysis of Soluble Mediators,Cytokines and FACs as Prognostic Factors in Advanced Non-squamous Lung Carcinoma
An observational study of Non-small Cell Lung Cancer, run by Spanish Lung Cancer Group at 25 sites in Spain.
Trial summary
Recent studies have shown that the assessment of a set of cytokines and / or circulating angiogenic factors (FACs) could be used to identify prognostic factors predictive of efficacy and / or potential mechanisms of resistance to antiangiogenic agents Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 153 participants
- Where
- 25 sitesSpain
- Study dates
- 3 Aug 2016to 30 Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced non-squamous lung carcinoma without molecular alterations susceptible to be treated with specific inhibitors (EGFR mutation, ALK translocation, ROS1 fusion) that have progressed to the first line of chemotherapy and are subsidiary to a second treatment line.
Who may be able to join
- Patients aged ≥ 18 years
- Histological and / or cytological confirmation of non-squamous pulmonary carcinoma, stage IIIB / IV or recurrent
- Failure to a first line of chemotherapy for advanced or recurrent disease. Patients who have received 2 treatment lines will also be included and this will be the 3 rd line provided that during one of the previous lines they have received immunotherapy or antidandial therapies (in patients with a wild type or unknown mutational status).
- ECOG 0 or 1
- Life expectancy greater than 12 weeks.
- Written informed consent of the patient in accordance with current regulations
Who cannot join
- Receive more than one line of chemotherapy treatment for advanced disease
- Hepatic function (one or more of the following values would exclude the patient): a. Total bilirubin outside the limits of normality; B. For patients without hepatic metastasis: ALT or AST> 1.5 times ULN; C. For patients with hepatic metastases: total bilirubin outside the limits of normality, ALT or AST> 2.5 times the ULN.
- Hemogram (one or more of the following values would exclude the patient): a. Absolute neutrophil count <1,500 / mm3; B. Platelets <100,000 / mm 3; C. Hemoglobin <9.0 g / dl.
- Situations such as the following: a. Active serious infections, especially if they require antimicrobial or systemic antibiotic treatment, or active or chronic infection with hepatitis C or B virus; B. Severe disease or non-oncological concomitant disease such as neurological, psychiatric or infectious disease or active ulcers (digestive tract, skin) or relevant analytical abnormality; C. Patients who are sexually active and do not want to use a medically acceptable method of contraception during the study and for at least 3 months after the completion of active treatment; D. Psychological, family, sociological or geographical factors; and. Alcoholism or current drug addiction; F. Preexisting ascites and / or clinically significant pleural effusion; G. Decompensated diabetes mellitus or other contraindication to treatment with corticosteroids at high doses
- Pregnancy or breastfeeding; The women must have obtained a negative result in a pregnancy test before starting the treatment
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
H.G.U. Alicante
Alicante, 03010
Hospital Universitario de la Ribera
Alzira, Valencia, 46600
ICO-Badalona
Badalona, Barcelona, 08916
Hospital Universitari Quirón Dexeus
Barcelona, 08028
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
H. Provincial de Castellón
Castelló, 12002
Hospital de Elche
Elche, Alicante, 03202
Hospital de Jaén
Jaén, 23007
Complejo Hospitalario Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016
Hospital Severo Ochoa
Leganés, Madrid, 28911
Hospital Lucus Agustí
Lugo, 27003
H.U. Puerta de Hierro
Madrid, 28035
H. Clínico San Carlos
Madrid
Hospital Costa del Sol
Marbella, Málaga, 29603
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, 07198
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital Clinico de Salamanca
Salamanca, 37007
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08190
Hospital Nuestra Señora Candelaria
Santa Cruz de Tenerife, 38010
Hospital Sant Pau i Santa Tecla
Tarragona, 43003
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08220
Hospital de Torrevieja
Torrevieja, Alicante, 03186
H. General U. de Valencia
Valencia, 46014
Hospital Dr. Peset
Valencia, 46017
Hospital de Sagunto
Valencia, 46500
About this study
Official title: Analysis of Soluble Mediators, Cytokines, and Circulating Angiogenic Factors (FACs) as Potential Predictors / Prognostic Factors in Antiangiogenic Therapy Following Failure of First-line Chemotherapy in Advanced Non-squamous Lung Carcinoma
Recent studies have shown that the assessment of a set of cytokines and / or circulating angiogenic factors (FACs) could be used to identify prognostic factors predictive of efficacy and / or potential mechanisms of resistance to antiangiogenic agents
Read the detailed description
Current management of patients with locally advanced or metastatic NSCLC, with no susceptible molecular alterations (EGFR mutation, ALK translocation, ROS1 fusion), includes combinations based on platinum in the first line of treatment, while in the second Line, there are three possibilities in monotherapy: docetaxel, erlotinib and pemetrexed. Pemetrexed is exclusively indicated for patients with a NSCLC of non-squamous histology. Although all of them have been shown to increase progression-free survival (PFS) and overall survival (OS), the median time to progression is maintained at 3 months, and the median overall survival at 8-9 months.
Recently, other therapeutic options have been incorporated in the context of the second line. Firstly, two antiangiogenic drugs: nintedanib and ramucirumab. The combination of nintedanib or ramucirumab with docetaxel in the second line of treatment has been shown to provide a significant increase in SLP and SG compared to docetaxel (9,11). One of the criticisms of the results of these two trials, common to all antiangiogenic treatments, is the lack of predictive factors that help us to better select the patients who would benefit from such treatment, as well as a better rationalization of Economic costs. On the other hand, recent data from new strategies based on immunotherapies in lung cancer indicate that nivolumab, a PD-1 antibody (Programmed cell death-1), has shown benefit in terms of survival versus docetaxel monotherapy both in Histology as squamous adenocarcinoma after failure to a platinum-based prior line.
Based on the above, the objective of this project is to analyze a panel of soluble mediators by means of multiparametric immunoassay techniques in samples of peripheral blood (at baseline, during treatment, and progression of the disease) obtained from patients With advanced lung adenocarcinoma, without molecular alterations treatable with anti-target drugs, that have progressed to a first line of chemotherapy, irrespective of whether they have received treatment with immunotherapies, and that they will be treated in the second line with chemotherapy (docetaxel) In combination or not with an antiangiogenic. It is a question of analyzing markers or panels of them with a prognostic / predictive meaning, as well as those that could be related to mechanisms of resistance to the administered treatments.
- Conditions
- Non-small Cell Lung Cancer
- 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.
Soluble mediators in relation to progression free survival
to correlate soluble mediators at progression time
Measured: At time of progression, an average of 1 year
Secondary outcomes (1)
Soluble mediators in relation to response rate
the soluble mediators will be measured in the blood sample at time of first response
Measured: at time of first response, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start3 Aug 2016
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Lung Cancer Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Camps, MD, Principal investigator, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156868
- Sponsor's protocol ID
- GECP 16/02_SELINA
- Status last verified
- Mar 2023
- First submitted
- 12 May 2017
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Soluble Mediators, Cytokines, and Circulating Angiogenic Factors (FACs) as Potential Predictors / Prognostic Factors in Antiangiogenic Therapy Following Failure of First-line Chemotherapy in Advanced Non-squamous Lung Carcinoma
- ClinicalTrials.gov ID
- NCT03156868
- Acronym / sponsor ID
- GECP 16/02_SELINA
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Spanish Lung Cancer GroupUniversity, hospital or other
- Study start
- 3 Aug 2016 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
Recent studies have shown that the assessment of a set of cytokines and / or circulating angiogenic factors (FACs) could be used to identify prognostic factors predictive of efficacy and / or potential mechanisms of resistance to antiangiogenic agents
Detailed description
Current management of patients with locally advanced or metastatic NSCLC, with no susceptible molecular alterations (EGFR mutation, ALK translocation, ROS1 fusion), includes combinations based on platinum in the first line of treatment, while in the second Line, there are three possibilities in monotherapy: docetaxel, erlotinib and pemetrexed. Pemetrexed is exclusively indicated for patients with a NSCLC of non-squamous histology. Although all of them have been shown to increase progression-free survival (PFS) and overall survival (OS), the median time to progression is maintained at 3 months, and the median overall survival at 8-9 months.
Recently, other therapeutic options have been incorporated in the context of the second line. Firstly, two antiangiogenic drugs: nintedanib and ramucirumab. The combination of nintedanib or ramucirumab with docetaxel in the second line of treatment has been shown to provide a significant increase in SLP and SG compared to docetaxel (9,11). One of the criticisms of the results of these two trials, common to all antiangiogenic treatments, is the lack of predictive factors that help us to better select the patients who would benefit from such treatment, as well as a better rationalization of Economic costs. On the other hand, recent data from new strategies based on immunotherapies in lung cancer indicate that nivolumab, a PD-1 antibody (Programmed cell death-1), has shown benefit in terms of survival versus docetaxel monotherapy both in Histology as squamous adenocarcinoma after failure to a platinum-based prior line.
Based on the above, the objective of this project is to analyze a panel of soluble mediators by means of multiparametric immunoassay techniques in samples of peripheral blood (at baseline, during treatment, and progression of the disease) obtained from patients With advanced lung adenocarcinoma, without molecular alterations treatable with anti-target drugs, that have progressed to a first line of chemotherapy, irrespective of whether they have received treatment with immunotherapies, and that they will be treated in the second line with chemotherapy (docetaxel) In combination or not with an antiangiogenic. It is a question of analyzing markers or panels of them with a prognostic / predictive meaning, as well as those that could be related to mechanisms of resistance to the administered treatments.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced non-squamous lung carcinoma without molecular alterations susceptible to be treated with specific inhibitors (EGFR mutation, ALK translocation, ROS1 fusion) that have progressed to the first line of chemotherapy and are subsidiary to a second treatment line.
Key inclusion criteria (6 listed)
- Patients aged ≥ 18 years
- Histological and / or cytological confirmation of non-squamous pulmonary carcinoma, stage IIIB / IV or recurrent
- Failure to a first line of chemotherapy for advanced or recurrent disease. Patients who have received 2 treatment lines will also be included and this will be the 3 rd line provided that during one of the previous lines they have received immunotherapy or antidandial therapies (in patients with a wild type or unknown mutational status).
- ECOG 0 or 1
- Life expectancy greater than 12 weeks.
Key exclusion criteria (5 listed)
- Receive more than one line of chemotherapy treatment for advanced disease
- Hepatic function (one or more of the following values would exclude the patient): a. Total bilirubin outside the limits of normality; B. For patients without hepatic metastasis: ALT or AST> 1.5 times ULN; C. For patients with hepatic metastases: total bilirubin outside the limits of normality, ALT or AST> 2.5 times the ULN.
- Hemogram (one or more of the following values would exclude the patient): a. Absolute neutrophil count <1,500 / mm3; B. Platelets <100,000 / mm 3; C. Hemoglobin <9.0 g / dl.
- Situations such as the following: a. Active serious infections, especially if they require antimicrobial or systemic antibiotic treatment, or active or chronic infection with hepatitis C or B virus; B. Severe disease or non-oncological concomitant disease such as neurological, psychiatric or infectious disease or active ulcers (digestive tract, skin) or relevant analytical abnormality; C. Patients who are sexually active and do not want to use a medically acceptable method of contraception during the study and for at least 3 months after the completion of active treatment; D. Psychological, family, sociological or geographical factors; and. Alcoholism or current drug addiction; F. Preexisting ascites and / or clinically significant pleural effusion; G. Decompensated diabetes mellitus or other contraindication to treatment with corticosteroids at high doses
- Pregnancy or breastfeeding; The women must have obtained a negative result in a pregnancy test before starting the 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
Soluble mediators in relation to progression free survival
Time frame: At time of progression, an average of 1 year
to correlate soluble mediators at progression time
1 secondary outcome
Soluble mediators in relation to response rate
Time frame: at time of first response, an average of 3 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 3 Mar 2023.
- Web page of the sponsor where users can find more information about Fundación GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Carlos Camps, MD principal investigator
Hospital General Universitario de Valencia
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Spanish Lung Cancer Group at 25 sites in Spain.
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 6 inclusion and 5 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 3 Mar 2023. 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 Spain. 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?
Soluble mediators in relation to progression free survival (time frame: At time of progression, an average of 1 year). 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 3 Mar 2023.