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:
2025-12-26 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
NCT ID:
NCT00347412
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Stage IIIb with malignant pleural or pericardial effusion or Stage IV (American Joint Committee on Cancer \[AJCC\]) NSCLC
* ECOG performance score of 0 or 1
* Adequate bone marrow, hepatic, and renal function
* New York Heart Association (NYHA) score 1-2
* Life expectancy of at least 12 weeks
* Women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years).
* The patient or patient's legal representative has the ability to understand the requirements of the trial, has provided written informed consent, and agrees to abide by the trial restrictions and to return for the required assessments.
* The patient must be able to self administer daily subcutaneous injections or his/her caregiver must be able to administer daily subcutaneous injections.
Exclusion Criteria:
* Prior chemotherapy for advanced NSCLC or the patient has received prior neoadjuvant or adjuvant chemotherapy for NSCLC in the year prior to the date of randomization
* Patients with central nervous system (CNS) metastases
* Any systemic disease precluding chemotherapy
* Chronic use of systemic corticosteroids in pharmacological doses
* Known or history of HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Contraindication to treatment with paclitaxel or carboplatin or any of the components of NOV-002
* Any known preexisting medical condition, including substance abuse, that could interfere with the patient's participation in and completion of the protocol
* Have received any investigational drug, defined as a drug for which there is no Food and Drug Administration (FDA) approved indication, within the 30 days prior to randomization
* Pregnant female or nursing mother
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00347412
Study Brief:
Protocol Section:
NCT00347412