Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.
Phase II study to determine progression free survival (PFS) of nab-paclitaxel administered in combination with gemcitabine, at two different dose combinations as first line therapy in patients with unresectable stage IIIB/stage IV non-squamous non-small cell lung cancer (NSCLC).
Checked against the public recordLast updated Nov 6, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- West Virginia University
- Interventions being studied
- Drug: Nab-paclitaxel; Drug: Gemcitabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- West Virginia University Hospitals - Mary Babb Randolph Cancer CenterMorgantown, West Virginia
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 6, 2017. Always confirm current availability with the study team.