A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer

Part of paid clinical trials in Edgewood, Kentucky.

Sponsor
Alliance Foundation Trials, LLC.
Study ID
NCT02967133
Phase
PHASE2
Status
Terminated

Conditions

  • Non Small Cell Lung Cancer Recurrent
  • Non-Small Cell Carcinoma of Lung, TNM Stage 4
  • Non-Small-Cell Lung Cancer Metastatic
  • Nonsmall Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated. Arm B: Nivolumab 360 mg via intravenous infusion (IV) over 30 minutes day 1 of every 21 day treatment cycle until progression or not tolerated.
  • nab-paclitaxel — DRUG
    Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.

Study Details

The optimal prioritization of second-line chemotherapy and immune therapy based on demographic or biomarker data is an area of ongoing investigation. The hypothesis of this study is that there may be an additive or synergistic antitumor effect of combined chemotherapy and nivolumab in the second-line treatment of NSCLC as an important concept to test in a clinical trial. Previously treated NSCLC remains a setting of unmet clinical need despite recent clinical research progress. Early progression for a subset of NSCLC patients receiving nivolumab is a specific area of clinical need.

Key Dates

Start date
Dec 31, 2016
Status verified
Aug 2022
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Nivolumab q 14 days until disease progression/toxicity
  • Active Comparator: Arm B
    Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days

Primary Outcome Measure

Progression-Free Survival [ Time Frame: 13 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
St. Elizabeth's HealthcareEdgewoodKentucky41017-
Metro Minnesota community oncology research consortiumSaint Louis ParkMinnesota55416-
Missouri Baptist Medical CenterSt LouisMissouri63131-
Nebraska Methodist HospitalOmahaNebraska68114-

Find similar trials in Edgewood, KY

By research site
St. Elizabeth's Healthcare· Edgewood, KYMetro Minnesota community oncology research consortium· Saint Louis Park, MNMissouri Baptist Medical Center· St Louis, MONebraska Methodist Hospital· Omaha, NE

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