Analysis of Soluble Mediators,Cytokines and FACs as Prognostic Factors in Advanced Non-squamous Lung Carcinoma
1 other identifier
observational
153
1 country
25
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2016
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 3, 2016
CompletedFirst Submitted
Initial submission to the registry
May 12, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMarch 3, 2023
March 1, 2023
3.9 years
May 12, 2017
March 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Soluble mediators in relation to progression free survival
to correlate soluble mediators at progression time
At time of progression, an average of 1 year
Secondary Outcomes (1)
Soluble mediators in relation to response rate
at time of first response, an average of 3 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Hospital de Elche
Elche, Alicante, 03202, Spain
Hospital de Torrevieja
Torrevieja, Alicante, 03186, Spain
ICO-Badalona
Badalona, Barcelona, 08916, Spain
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, 08190, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08220, Spain
Complejo Hospitalario Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016, Spain
Hospital Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, 07198, Spain
Hospital Costa del Sol
Marbella, Málaga, 29603, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario de la Ribera
Alzira, Valencia, 46600, Spain
H.G.U. Alicante
Alicante, 03010, Spain
Hospital Universitari Quirón Dexeus
Barcelona, 08028, Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041, Spain
H. Provincial de Castellón
Castelló, 12002, Spain
Hospital de Jaén
Jaén, 23007, Spain
Hospital Lucus Agustí
Lugo, 27003, Spain
H.U. Puerta de Hierro
Madrid, 28035, Spain
H. Clínico San Carlos
Madrid, Spain
Hospital Clinico de Salamanca
Salamanca, 37007, Spain
Hospital Nuestra Señora Candelaria
Santa Cruz de Tenerife, 38010, Spain
Hospital Sant Pau i Santa Tecla
Tarragona, 43003, Spain
H. General U. de Valencia
Valencia, 46014, Spain
Hospital Dr. Peset
Valencia, 46017, Spain
Hospital de Sagunto
Valencia, 46500, Spain
Related Links
Biospecimen
Soluble mediators analyzed (cytokines, FACs)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Camps, MD
Hospital General Universitario de Valencia
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2017
First Posted
May 17, 2017
Study Start
August 3, 2016
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
March 3, 2023
Record last verified: 2023-03