Ph2 Nab-paclitaxel With Gemcitabine to Determine Efficacy in Advanced Non-squamous NSCLC.

• Status: Withdrawn
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: West Virginia University
• Collaborator: Celgene Corporation
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

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.