Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.
Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring advanced, non-squamous, first line therapy
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically proven newly diagnosed stage IV or stage IIIB non-squamous Non-small Cell Lung Cancer (NSCLC) - Recurrent advanced NSCLC will be allowed if they have never received chemotherapy for metastatic disease. - Prior adjuvant chemotherapy will be allowed, if recurrence occurred ≥ 6 months after last treatment
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Washout period of 4 weeks for chemo/radiation/experimental agents
- Resolution of all toxicities to < grade 2 prior to starting treatment (excluding alopecia)
- Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE)
- Adequate hepatic, renal, and bone marrow functions
- Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
- Negative serum or urine β-hCG pregnancy test at screening for patients of childbearing potential
Exclusion Criteria:
- Patient with New York Heart Association class III or IV heart failure
- Women of child bearing potential (WOCBP) are not currently pregnant or breast-feeding
- Co-existing malignancy or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma
- Previous anaphylactic or severe allergic reaction to paclitaxel and/or docetaxel will be excluded
- Grade ≥2 peripheral neuropathy at baseline assessment from any cause
- Symptomatic brain metastases will be excluded. Treated Brain metastases will be allowed that are neurologically stable.
- Patients with adenocarcinoma with activating EGFR mutation (exon 19 deletions / insertions, exon 21 point mutations) or EML4-ALK translocation are excluded unless they are ineligible for epidermal growth factor receptor (EGFR) or ALK targeting agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Sites / Locations
- West Virginia University Hospitals - Mary Babb Randolph Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
A - Nab-paclitaxel 100mg + Gemcitabine 1250mg
B - Nab-paclitaxel 125mg + Gemcitabine 1000mg
Nab-paclitaxel 100 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on days 1, 8 and 15 of a 21 day cycle. On days 1 and 8 of each cycle, nab-paclitaxel administration will be followed by the administration of gemcitabine 1250 mg/m2 as a 30 minute infusion (maximum 40 minutes).
Nab-paclitaxel 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on days 1, 8 and 15 of a 28 day cycle. Each nab-paclitaxel administration will be followed by the administration of gemcitabine 1000 mg/m2 as a 30 minute infusion (maximum 40 minutes) on days 1, 8 and 15. Treatments will be repeated until progression or intolerance.