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Lung CancerPhase 2NCT02328105

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

A Phase 2 study testing Carboplatin and Abraxane in people with Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
Carboplatin and Abraxane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Dec 2014to 6 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Levine Cancer Institute

    Charlotte, North Carolina, 28203

Other trials in United States

About this study

Official title: LCI-LUN-ABR-001: A Pilot Study of Carboplatin With Nab-Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer of Squamous Histology

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.

Read the detailed description

This is a single arm phase II study for subjects receiving first line therapy for metastatic squamous cell lung cancer. Following informed consent and eligibility check, all subjects will receive therapy with carboplatin and ABRAXANE on an outpatient basis. A total of 50 subjects will be enrolled over an enrollment period of about 24 months. Interim analyses will be conducted after the enrollment of subject 15, subject 30, and subject 45. Tissue biomarkers will be analyzed at baseline; and blood biomarkers will be analyzed at baseline, pre-dose on cycles 3 and 5, and then within 30 days of last dose of study treatment.

Conditions
Lung Cancer
Being tested
Carboplatin, Abraxane
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Dosing: AUC = 6; on Day 1

  • AbraxaneDrug

    Also called nab-paclitaxel

    100 mg/m^2; Days 1, 8, 15

Study groups in NCT02328105
Study groupRoleWhat they receive
Carboplatin + AbraxaneExperimentalCarboplatin (AUC = 6; on Day 1) plus Abraxane (nab-paclitaxel; 100 mg/m^2; Days 1, 8, 15) for 6 21-day cycles. Treatment was discontinued if: disease progression, unacceptable toxicity, withdrawn consent, or completion of treatment
Receives: Drug: Carboplatin; Drug: Abraxane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With a Response

    The primary endpoint is a binary variable determined for each patient indicating whether or not they achieved a complete response (CR) or a partial response (PR) as per RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions and a PR is indicated by >= 30% decrease in sum of longest diameter of target lesions with baseline as reference). Because overall response is the primary endpoint for this study, best responses of CR or PR must be confirmed by a subsequent radiologic assessment.

    Measured: Up to a planned 18 weeks

Secondary outcomes (5)

  1. Number of Subjects With Stable Disease or Response

    Disease control is calculated for each subject indicating whether or not they achieved an overall response of stable disease or better by RECIST 1.1 (where a CR is indicated by disappearance of all target and non target lesions, a PR is indicated by >= 30% decrease in sum of longest diameter of target lesions with baseline as reference, and SD is neither sufficient shrinkage to qualify for PR nor sufficient growth, >=20%, to indicate progression).

    Measured: 18 weeks

  2. Progression Free Survival

    PFS is defined as time from enrollment to time of progression or death. Disease progression (PD) may be determined objectively per RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of longest diameters of target lesions, a measurable increase in non-target lesion, or appearance of new lesions) or subjectively as determined by investigator (with evidence documented in the medical records). If the subject died without documented PD, date of progression will be date of death. For surviving subjects who did not have documented PD, PFS was censored at last radiologic assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS was censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experienced a PFS event following an interval equal to two or more scheduled radiologic assessments were censored at last assessment prior to first missed assessment.

    Measured: From date of treatment start to date of progression/death, or censored as described above; assessed for approximately 3 years

  3. Overall Survival

    OS is defined as the duration of time from enrollment to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive.

    Measured: From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years

  4. Duration of Response

    For subjects who achieve a CR or PR, response duration will be measured from the first day of the response until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.

    Measured: From date of response to date of progression/death, or censored as described above; assessed for approximately 3 years.

  5. Duration of Disease Control

    For subjects who achieve SD or better, duration of disease control will be measured from the treatment start date until the day on which progressive disease (PD) or death occurred. The censoring method will be the same as that described for PFS.

    Measured: From date of treatment start to date of progression, or censored as described above; assessed for approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion15 Jun 2017
  4. Study completion6 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02328105
Sponsor's protocol ID
LCI-LUN-ABR-001
Other IDs
00010224
Status last verified
May 2021
First submitted
17 Dec 2014
Last updated
9 Aug 2022
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin and Abraxane in people with Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Response (time frame: Up to a planned 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02328105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.

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