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 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT01004250
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of nonsquamous Stage IIIB or Stage IV NSCLC that is not amenable to curative therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* At least 1 unidimensionally measurable lesion meeting the Response Evaluation Criteria In Solid Tumors (RECIST) criteria
* Adequate organ function, including the following:
* Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 10\^9 per Liter (10\^9/L), platelets ≥100 x 10\^9/L, and hemoglobin ≥10 gram per deciliter (g/dL)
* Hepatic: bilirubin ≤1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤3.0 x ULN (AP, AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement)
* Renal: calculated creatinine clearance (CrCl) ≥45 milliliter per minute (mL/min) based on the original weight-based Cockcroft and Gault formula, and serum creatinine ≤1.5 x ULN
* At the time of enrollment, if the urinalysis dipstick result is ≥2+ for protein, a 24-hour urine collection should be taken. In these cases, participants must have ≤1g protein/24 hours to be eligible for study participation
* Participants must sign an Informed Consent Document (ICD)
Exclusion Criteria:
* Have received prior systemic anticancer therapy for lung cancer (including adjuvant early-stage treatment for NSCLC)
* Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV
* Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
* Have known central nervous system (CNS) disease, other than stable, treated brain metastasis. Stable, treated brain metastasis is defined as metastasis having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and post-treatment brain imaging (Computed Tomography \[CT\] scan or magnetic resonance imaging \[MRI\])
* Are receiving concurrent administration of any other antitumor therapy
* Have a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis
* Have had significant weight loss (that is, ≥10%) over the previous 6 weeks before study entry
* Have a history of gross hemoptysis (bright red blood of ≥½ teaspoon per episode of coughing) \<3 months prior to enrollment or history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
* Are taking or have recently taken (within 10 days of enrollment) full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes. Prophylactic use of anticoagulants is allowed; international normalized ratio (INR) should be \<1.5 at study enrollment
* Have a history of hypertension, unless hypertension is well controlled upon study entry (≤150/90 millimeter of mercury \[mm Hg\]) and the participant is on a stable regimen of antihypertensive therapy. Participants should not have any prior history of hypertensive crisis or hypertensive encephalopathy
* Have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to study enrollment, or anticipate the need for major surgical procedure during the course of the study
* History of thrombotic disorders within the last 6 months prior to entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01004250
Study Brief:
Protocol Section:
NCT01004250