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

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

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer

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 Type: Observational
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03010
    • H.G.U. Alicante
  • Barcelona, Spain, 08041
    • Hospital de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08028
    • Hospital Universitari Quiron Dexeus
  • Castelló, Spain, 12002
    • H. Provincial de Castellón
  • Jaén, Spain, 23007
    • Hospital de Jaen
  • Lugo, Spain, 27003
    • Hospital Lucus Agustí
  • Madrid, Spain
    • H. Clínico San Carlos
  • Madrid, Spain, 28035
    • H.U. Puerta de Hierro
  • Salamanca, Spain, 37007
    • Hospital Clinico De Salamanca
  • Santa Cruz de Tenerife, Spain, 38010
    • Hospital Nuestra Señora Candelaria
  • Tarragona, Spain, 43003
    • Hospital Sant Pau i Santa Tecla
  • Valencia, Spain, 46017
    • Hospital Dr. Peset
  • Valencia, Spain, 46500
    • Hospital de Sagunto
  • Valencia, Spain, 46014
    • H. General U. de Valencia
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Hospital de Elche
    • Torrevieja, Alicante, Spain, 03186
      • Hospital de Torrevieja
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • ICO-Badalona
    • Sant Cugat Del Vallès, Barcelona, Spain, 08190
      • Hospital General de Catalunya
    • Terrassa, Barcelona, Spain, 08220
      • Consorci Sanitari de Terrassa
  • Gran Canaria
    • Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
      • Complejo Hospitalario Universitario Insular de Gran Canaria
  • Madrid
    • Leganés, Madrid, Spain, 28911
      • Hospital Severo Ochoa
  • Mallorca
    • Palma De Mallorca, Mallorca, Spain, 07198
      • Hospital Son Llatzer
  • Málaga
    • Marbella, Málaga, Spain, 29603
      • Hospital Costa del Sol
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra
  • Valencia
    • Alzira, Valencia, Spain, 46600
      • Hospital Universitario de la Ribera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Spanish Lung Cancer Group
• Investigators: Principal Investigator: Carlos Camps, MD, Hospital General Universitario de Valencia

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2016
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: GECP 16/02_SELINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No