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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT01183858
Eligibility Criteria:
Inclusion Criteria:
* Adult patients aged ≥18 years
* inoperable, locally advanced (stage IIIB/IV) with supraclavicular lymph node metastases or malignant pleural or pericardial effusion) or metastatic (stage IV) non-small cell lung cancer (NSCLC)
* Disease must be characterized according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Patients have received one prior platinum-based chemotherapy regimen for advanced NSCLC, but must have recovered from any treatment-related toxicity
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy ≥12 weeks
* Current cigarette smoker (having smoked \>100 cigarettes in entire lifetime and currently smoking on average ≥1 cigarette per day), not intending to stop during the study
Exclusion Criteria:
* Prior antibody or small molecule therapy against Epidermal growth factor receptor (EGFR)
* Radiotherapy within 28 days prior to enrollment
* Received more than one line of chemotherapy for locally advanced/metastatic NSCLC (first-line maintenance chemotherapy after first-line platinum-based chemotherapy is allowed)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01183858
Study Brief:
Protocol Section:
NCT01183858