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).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Nov 6, 2017 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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.