Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT03156868
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03156868
Study Brief:
Protocol Section:
NCT03156868