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 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT02826161
Eligibility Criteria:
Key Inclusion Criteria:
* Must have histologically or cytologically confirmed non-squamous NSCLC.
* Must have progressed following treatment with platinum-based combination chemotherapy for metastatic disease, and patients with an EGFR or ALK/ROS1 genetic aberration must have received appropriately targeted treatment.
* Must have received either nivolumab or pembrolizumab or a different IND-approved anti-PD1 or anti-PD-L1 therapy, unless medically contraindicated
* Weekly paclitaxel must be an acceptable treatment option
* Must submit tumor tissue for correlative analyses
* Women of child-bearing potential and partners of women of child-bearing potential must take measures to avoid pregnancy while receiving and for a period of time following protocol therapy
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, adequate organ function, and a life expectancy of ≥ 3 months
Key Exclusion Criteria:
* Has squamous NSCLC
* Has received prior systemic treatment with a taxane for advanced/metastatic disease
* Has received systemic anti-cancer therapy within the 14 days prior to randomization
* Has received radiotherapy within the 28 days prior to randomization, with the exception of palliative radiotherapy to focal lesions for pain or other symptom control
* Has brain metastases with evolving neurologic symptoms or a steroid requirement.
* Has had major surgery requiring general anesthesia and/or mechanical ventilation within the 28 days prior to randomization
* Has a corrected QT interval (QTc) \> 470 ms or has an electrocardiogram (ECG) with a new abnormal finding that is clinically significant
* Has peripheral neuropathy ≥ Grade 2 (NCI-CTCAE)
* Refuses to complete quality of life questionnaires either alone or with assistance from study staff despite adequate fluency
* Has an intercurrent (non-malignant) chronic medical or psychiatric illness or condition(s) not optimally controlled and carrying a moderate to high risk of interfering with protocol therapy administration or compliance with required procedures, in the judgment of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02826161
Study Brief:
Protocol Section:
NCT02826161