LCI-LUN-ABR-001: Carbo With Nab-Paclitaxel in Patients With Advanced NSCL Cancer

Study summary

ABRAXANE, based on results from prior studies, is a promising drug in squamous cell carcinoma of the lung. This study will help to explore the combination of ABRAXANE and carboplatin more thoroughly in the subgroup of patients who had the best response in prior studies as well as determine whether there are any biomarkers which can predict for response.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCarboplatin and Abraxane

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 9, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Wake Forest University Health Sciences
Interventions being studied: Drug: Carboplatin; Drug: Abraxane

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Chemotherapy→

Public criteria

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.

Requirements people may need to meetInclusion criteria

Histologically confirmed stage IV non-small cell lung cancer with predominantly squamous histology
No prior systemic treatment for metastatic disease. Patients who have received prior adjuvant chemotherapy for early-stage lung cancer are eligible if at least 12 months have elapsed between the date of final chemotherapy administration and the date of consent
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>20 mm with conventional techniques or as \>10 mm with CT scan, MRI, or calipers by clinical exam
Biopsy accessible disease
Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Definitive radiation therapy must have been completed \>4 weeks prior to the date the informed consent is signed
Age \>18 years
ECOG performance status less than or equal to 1
If patient has brain metastasis, the disease must be stable (treated and/or asymptomatic) for at least 4 weeks prior to first dose of study treatment
Bilirubin \< 1.5 mg/dL
Adequate liver function: AST and ALT \<= 2.5x upper limit of normal, alkaline phosphatase \<= 2.5x upper limit of normal, unless bone metastasis is present (\< 5x upper limit of normal) in the absence of liver metastasis
Adequate bone marrow function: Platelets \>100,000 cells/mm3, Hemoglobin \> 9.0g/dL and ANC \> 1,500 cells/mm3
Adequate renal function with creatinine \<1.5 mg/dL is recommended
Females of childbearing potential and sexually active males must use an effective contraception method during treatment and for six months after completing treatment
Negative serum or urine B-hCG pregnancy test at screening for patients of childbearing potential
Patients must have \< Grade 2 pre-existing peripheral neuropathy (per CTCAE version 4.0)
Ability to understand and the willingness to sign a written informed consent document

Reasons someone may not be able to joinExclusion criteria

Received prior systemic therapy for metastatic disease
Received limited field radiation for palliation \<= 2 weeks prior to starting study treatment and/or from whom \>= 30% bone marrow was irradiated
Receiving any other investigational agents
Known hypersensitivity to either carboplatin or ABRAXANE
Uncontrolled and current 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
Pregnant or breast feeding
Other active malignancies
Neuropathy greater than or equal to grade 2

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Levine Cancer InstituteCharlotte, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 9, 2022. Always confirm current availability with the study team.

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