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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03156868
• Other study ID #: GECP 16/02_SELINA
• Status: Completed
• Start date: August 3, 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2023
• Source: Spanish Lung Cancer Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
Spain	H.G.U. Alicante	Alicante
Spain	Hospital Universitario de la Ribera	Alzira	Valencia
Spain	ICO-Badalona	Badalona	Barcelona
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital Universitari Quirón Dexeus	Barcelona
Spain	H. Provincial de Castellón	Castelló
Spain	Hospital de Elche	Elche	Alicante
Spain	Hospital de Jaén	Jaén
Spain	Complejo Hospitalario Universitario Insular de Gran Canaria	Las Palmas de Gran Canaria	Gran Canaria
Spain	Hospital Severo Ochoa	Leganés	Madrid
Spain	Hospital Lucus Agustí	Lugo
Spain	H. Clínico San Carlos	Madrid
Spain	H.U. Puerta de Hierro	Madrid
Spain	Hospital Costa del Sol	Marbella	Málaga
Spain	Hospital Son Llàtzer	Palma De Mallorca	Mallorca
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital Clinico de Salamanca	Salamanca
Spain	Hospital General de Catalunya	Sant Cugat Del Vallès	Barcelona
Spain	Hospital Nuestra Señora Candelaria	Santa Cruz de Tenerife
Spain	Hospital Sant Pau i Santa Tecla	Tarragona
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital de Torrevieja	Torrevieja	Alicante
Spain	H. General U. de Valencia	Valencia
Spain	Hospital de Sagunto	Valencia
Spain	Hospital Dr. Peset	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Lung Cancer Group

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Soluble mediators in relation to response rate	the soluble mediators will be measured in the blood sample at time of first response	at time of first response, an average of 3 months

External Links

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