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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 March 2023
• Main ID: NCT03156868
• Date of registration: 12/05/2017
• Prospective Registration: No
• Primary sponsor: Spanish Lung Cancer Group
• Public title: Analysis of Soluble Mediators,Cytokines and FACs as Prognostic Factors in Advanced Non-squamous Lung Carcinoma
• Scientific 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
• Date of first enrolment: August 3, 2016
• Target sample size: 153
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03156868
• Study type: Observational

Countries of recruitment

Spain

Contacts

• Name: Carlos Camps, MD
• Affiliation: Hospital General Universitario de Valencia

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-small Cell Lung Cancer

Primary Outcome(s)

Soluble mediators in relation to progression free survival [Time Frame: At time of progression, an average of 1 year]

Secondary Outcome(s)

Soluble mediators in relation to response rate [Time Frame: at time of first response, an average of 3 months]

Secondary ID(s)

GECP 16/02_SELINA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors