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:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT00955305
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed with non-squamous, non-small cell lung cancer (NSCLC)
* Advanced NSCLC defined as either recurrent disease after prior radiation or surgery or stage IV (M1a or M1b) based on the TNM staging system (American Joint Committee on Cancer \[AJCC\] 2009)
* Measurable disease as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). All sites of disease (of target and non-target disease sites) must be obtained within 4 weeks prior to randomization
* A head computed tomography (CT) or magnetic resonance imaging (MRI) required within 4 weeks prior to randomization
* Prior radiation therapy (RT) is allowed if it has been completed 3 weeks prior to randomization and patient has recovered from any adverse events related to RT
* Brain metastases are allowed, provided they have been treated with surgery and/or radiotherapy, the patient is neurologically stable, and repeat brain imaging shows no progression in the brain; at least 6 weeks should have elapsed from the time of craniotomy and at least 4 weeks from radiotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Absolute neutrophil count (ANC) ≥ 1500/mm³
* Platelet count ≥ 100,000/mm³
* Total bilirubin within institutional upper limit of normal (ULN)
* Serum creatinine ≤ 1.5 x ULN
* Fasting blood glucose within normal range (fasting \< 120 mg/dL or below ULN)
* Alkaline phosphatase (ALP) ≤ 3 x ULN
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN
* Urine dipstick must be ≤ 0-1+ within 2 weeks (14 days) of randomization; if urine dipstick result is \> 1+, a calculation of urine protein creatinine (UPC) ratio is required; patients must have a UPC ratio \< 1.0 to participate in the study
* Neuropathy, if present at baseline, must be ≤ Common Terminology Criteria for Adverse Events (CTCAE) grade 1
* Patients with a history of hypertension must be well-controlled (≤ 150/90) on a stable regimen of anti-hypertensive therapy
* Women of childbearing potential and sexually active males should use an accepted and effective method of contraception while on treatment and for 3 months thereafter
Exclusion Criteria:
* Prior chemotherapy or biologic/molecular targeted therapy for advanced NSCLC. Prior chemotherapy and/or biological/molecular targeted therapy as part of initial potentially curative therapy (one regimen of induction and/or adjuvant and/or concurrent chemoradiotherapy) was allowed provided it had been completed 1 year or more prior to randomization
* Prior treatment with IMC-A12 or another insulin-like growth factor 1 receptor (IGF-1R) inhibitor
* Patients on therapeutic anticoagulation; patient's international normalized ratio (INR) must be ≤ 1.5 or partial thromboplastin time (PTT) ≤ upper limits of normal within 2 weeks prior to randomization to be eligible; prophylactic anticoagulation of venous access devices is allowed provided the above criteria have been met
* Prior allergic reaction to compounds of chemical or biologic composition similar to those of IMC-A12
* Hypersensitivity to any component of bevacizumab
* Poorly controlled diabetes mellitus
* History of other invasive malignancies unless there is no active disease and all treatment has been completed ≥ 3 years prior to randomization; patients with history of in-situ malignancies and curatively resected nonmelanomatous skin cancer are eligible
* History of thrombotic or hemorrhagic disorders
* History of bleeding diathesis or coagulopathy
* ≥ grade 2 bleeding or any bleeding requiring intervention within 4 weeks prior to randomization
* History of gross hemoptysis (defined as ≥ 1/2 teaspoon of bright red blood)
* Any of the following within 6 months prior to randomization:
* Abdominal fistula
* Gastrointestinal perforation
* Intra-abdominal abscess
* Previous myocardial infarction
* History of any central nervous system (CNS) cerebrovascular ischemia
* New York Heart Association (NYHA) \> class II congestive heart failure or severe heart failure
* Unstable or symptomatic angina pectoris
* History of stroke
* Significant vascular disease
* Symptomatic peripheral vascular disease
* Ongoing, serious cardiac arrhythmia requiring medication at time of randomization
* Ongoing, active infection or ongoing fever at the time of randomization or any co-existing medical condition, psychiatric illness or limitations that would interfere with compliance of study requirements
* History of hypertensive crisis or hypertensive encephalopathy
* Any of the following within 4 weeks prior to randomization: a serious non-healing wound, ulcer, bone fracture, or major surgical procedure
* Anticipated major surgical procedure(s) during the course of the study
* Receiving daily treatment with aspirin (\> 325 mg/day) or non-steroidal anti-inflammatory agents (NSAIDs) known to inhibit platelet function for chronic conditions; patients must not be receiving treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), and/or cilostazol (Pletal); if patient was receiving any of the following: aspirin (\> 325 mg/day), NSAID, and/or anti-platelet drugs, patient must have discontinued its use ≥ 1 week prior to randomization
* Pregnant or breast-feeding
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00955305
Study Brief:
Protocol Section:
NCT00955305