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 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT01519804
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* No prior chemotherapy for squamous NSCLC
* Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
* Radiographic evidence of disease
Exclusion Criteria:
* Prior systemic treatment for Stage IIIB or IV squamous NSCLC
* NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
* Prior exposure to experimental treatment targeting either the HGF or Met pathway
* Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
* Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
* History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
* Pregnant or lactating women
* Uncontrolled diabetes
* Impaired bone marrow, liver or renal function as defined by protocol
* Significant history of cardiovascular disease
* Positive for HIV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01519804
Study Brief:
Protocol Section:
NCT01519804