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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT00879866
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed NSCLC stage IIIb with malignant pleural effusion or stage IV
* Pulmonary primary tumor or at least one NSCLC metastasis in the lung measuring at least 1 cm in diameter and eligible for local radiation with 20 Gy
* Disease control (partial remission or stable disease) after 4 cycles of platinum-based first-line chemotherapy whereby the time between the last dose of first-line chemotherapy and start of trial treatment should not be longer than 8 weeks
* Male or female, aged ≥18 years of age
* Signed written informed consent
* Effective contraception for male and female subjects of childbearing age
* ECOG performance status 0 or 1
* Adequate hematological function defined by WBC ≥3 x 10\^9/L, neutrophils ≥1.5 x 10\^9/L, lymphocyte count ≥0.5 x 10\^9/L, platelet count ≥100 x 10\^9/L; hemoglobin ≥9 g/dL
* Estimated creatinine clearance ≥50 mL/min according to the Cockcroft - Gault formula or 24-h urine sampling
* Adequate hepatic function defined by a total bilirubin level ≤1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 x ULN
Exclusion Criteria:
* Requirement for immunosuppressive treatment with the exception of inhalative corticosteroids or low-dose systemic corticosteroids (prednisone equivalent dose ≤10 mg/day)
* Systemic autoimmune disease (e.g. lupus erythematodes, rheumatoid arthritis)
* Organ transplant recipients
* Active infections (including HIV, hepatitis B and C, tuberculosis)
* Known or clinically suspected brain metastases
* Active cardiovascular/cerebrovascular disease (e.g. symptomatic coronary vascular disease, congestive heart failure ≥ NYHA II, LVEF \<50%, ventricular arrhythmia requiring medication, myocardial infarction or stroke) within previous 6 months
* Pericardial effusion
* Major impairment in pulmonary function: forced expir¬atory volume in 1 second (FEV1) \<50% and diffusion capacity for carbon monoxide (DLCO) \<50% of normal limit
* Any other significant disease that in the Investigator's opinion would exclude the subject from the trial
* Known conditions associated with necroses of non-tumor bearing tissues (e.g. esophageal or gastroduodenal ulcers, ischemic bowel disease, chronic inflammations)
* Pregnancy or lactation
* Radiotherapy, chemotherapy, major surgery, biological therapy or any investigational drug within 30 days prior to the start of trial treatment
* Requirement for concurrent systemic anticancer treatment (chemotherapy, biological therapy)
* Pretreatment with anti-EGFR antibodies or tyrosine kinase inhibitors
* Participation in another interventional clinical trial within the past 30 days before start of trial treatment
* Known alcohol or drug abuse
* Any psychiatric condition that would prohibit the understanding or rendering of the informed consent
* Legal incapacity or limited legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00879866
Study Brief:
Protocol Section:
NCT00879866