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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT01560104
Eligibility Criteria:
Inclusion Criteria: - Life expectancy \> 12 weeks (as per Investigator's clinical assessment).
* Subject must have cytologically or histologically confirmed non-small cell lung cancer (NSCLC).
* Subject must have metastatic or advanced non-small cell lung cancer (NSCLC) (stage IIIB or IV) that is not amenable to surgical resection or radiation with curative intent at time of study Screening.
* Subject must have at least 1 unidimensional measurable non-small cell lung cancer (NSCLC) lesion on a Computed Tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1).
* Subject must consent to provide available archived formalin fixed, paraffin embedded (FFPE) tissue sample of non-small cell lung cancer (NSCLC) lesion (primary or metastatic) for central review and biomarker analysis.
* Subject must have no history of brain metastases or evidence of primary central nervous system (CNS) tumors as demonstrated by a baseline magnetic resonance imaging (MRI).
* Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
* Subjects with fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the Investigator.
Exclusion Criteria: -Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
* Subject has a known hypersensitivity to platinum compounds.
* Subjects with peripheral neuropathy ≥ grade 2.
* Subjects with a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21. (Subjects with wild type epidermal growth factor receptor (EGFR), unknown status or other type of epidermal growth factor receptor (EGFR) mutation will be considered eligible).
* Subject has received prior systemic anti-cancer therapy for metastatic non-small cell lung cancer (NSCLC).
* Subject has received adjuvant chemotherapy ≤ 12 months prior to Cycle 1 Day 1.
* Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day 1.
* Subject has undergone External Beam Radiation Therapy (EBRT) ≤ 8 weeks prior to Cycle 1 Day 1.
* Clinically significant and uncontrolled major medical condition(s).
* Subject has previously been treated with a poly-(ADP-ribose)-polymerase (PARP) inhibitor
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT01560104
Study Brief:
Protocol Section:
NCT01560104