Analysis of Soluble Mediators,Cytokines and FACs as Prognostic Factors in Advanced Non-squamous Lung Carcinoma

NCT ID: NCT03156868

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 153 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-03
• Study Completion Date: 2020-06-30

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

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Patients aged ≥ 18 years

2. Histological and / or cytological confirmation of non-squamous pulmonary carcinoma, stage IIIB / IV or recurrent

3. 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).

4. ECOG 0 or 1

5. Life expectancy greater than 12 weeks.

6. Written informed consent of the patient in accordance with current regulations

Exclusion Criteria

1. Receive more than one line of chemotherapy treatment for advanced disease

2. 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.

3. 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.

4. 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

5. Pregnancy or breastfeeding; The women must have obtained a negative result in a pregnancy test before starting the treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Lung Cancer Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos Camps, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario de Valencia

Locations

Hospital de Elche

Elche, Alicante, Spain

Hospital de Torrevieja

Torrevieja, Alicante, Spain

ICO-Badalona

Badalona, Barcelona, Spain

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Complejo Hospitalario Universitario Insular de Gran Canaria

Las Palmas de Gran Canaria, Gran Canaria, Spain

Hospital Severo Ochoa

Leganés, Madrid, Spain

Hospital Son Llàtzer

Palma de Mallorca, Mallorca, Spain

Hospital Costa del Sol

Marbella, Málaga, Spain

Clínica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Universitario de la Ribera

Alzira, Valencia, Spain

H.G.U. Alicante

Alicante, , Spain

Hospital Universitari Quirón Dexeus

Barcelona, , Spain

Hospital de La Santa Creu I Sant Pau

Barcelona, , Spain

H. Provincial de Castellón

Castelló, , Spain

Hospital de Jaén

Jaén, , Spain

Hospital Lucus Agustí

Lugo, , Spain

H.U. Puerta de Hierro

Madrid, , Spain

H. Clínico San Carlos

Madrid, , Spain

Hospital Clinico de Salamanca

Salamanca, , Spain

Hospital Nuestra Señora Candelaria

Santa Cruz de Tenerife, , Spain

Hospital Sant Pau i Santa Tecla

Tarragona, , Spain

H. General U. de Valencia

Valencia, , Spain

Hospital Dr. Peset

Valencia, , Spain

Hospital de Sagunto

Valencia, , Spain

Countries

Spain

Related Links

http://www.gecp.org

Web page of the sponsor where users can find more information about Fundación GECP studies

Other Identifiers

GECP 16/02_SELINA

Identifier Type: -

Identifier Source: org_study_id