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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00735904
Eligibility Criteria:
Inclusion Criteria:
* Histologically- or cytologically-confirmed diagnosis of squamous NSCLC Stage IIIB with malignant effusion (fluid cytology demonstrating malignant cells required), Stage IV, or recurrent disease after definitive local therapy
* Candidate for primary treatment with cisplatin and gemcitabine
* Presence of measurable disease by RECIST
* Adequate organ function as defined by the following criteria: ECOG performance status of 0 or 1
Exclusion Criteria:
* Prior systemic treatment for Stage IIIB (with malignant effusion) or Stage IV NSCLC.
* One or more lung lesions with cavitation, or any lesion invading or abutting a major blood vessel as assessed by CT or MRI.
* History of hemoptysis \> ½ tsp (2.5 ml) of blood per day for a day or more within 1 week of study treatment, or Grade 3 or 4 hemoptysis within 4 weeks of study treatment
* NCI CTCAE Grade 3 hemorrhage from any cause within 4 weeks of study treatment
* Preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
* Untreated brain metastases.
* Need for therapeutic anticoagulation, regular use of aspirin (\> 325 mg/day), NSAID or other medications known to inhibit platelet function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00735904
Study Brief:
Protocol Section:
NCT00735904