Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor

Part of paid clinical trials in Anderson, Indiana.

Sponsor
Nasser Hanna, M.D.
Study ID
NCT03041181
Phase
PHASE2
Status
Terminated

Conditions

  • Adenocarcinoma of the Lung
  • Lung Cancer
  • Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
  • Squamous Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Docetaxel — DRUG
    Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
  • Nivolumab — DRUG
    Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle)
  • Gemcitabine — DRUG
    Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)
  • Pemetrexed — DRUG
    Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)

Study Details

This is a randomized phase II study assessing the activity of single agent chemotherapy combined with nivolumab (Arm A) compared to single agent chemotherapy alone (Arm B) in squamous or non-squamous NSCLC subjects with primary resistance to prior PD-1 or PDL-1 inhibitor. The single agent chemotherapy chosen is at the discretion of the site investigator and may include pemetrexed, gemcitabine or taxotere. Institutional standards should be used for administration of the single agent chemotherapy. For both treatment arms, 21 days equals 1 cycle of therapy and subjects will be eligible to continue treatment until progressive disease by RECIST v1.1 or unacceptable toxicity. Upon registration, subjects will be randomized in a 1:1 ratio to either treatment with single agent chemotherapy or single agent chemotherapy in combination with nivolumab. Randomization is un-blinded and open-label; therefore there will be no placebo treatment for subjects randomized to single agent chemotherapy

Key Dates

Start date
Jan 27, 2017
Status verified
Jul 2022
Primary completion
May 23, 2019
Completion
May 23, 2019

Study Design

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

Arms

  • Experimental: Arm A - Single Agent Chemotherapy + Nivolumab
    Single Agent Chemotherapy of choice plus nivolumab: Taxotere Pemetrexed Gemcitabine
  • Active Comparator: Arm B - Single Agent Chemotherapy
    Single Agent Chemotherapy of choice Taxotere Pemetrexed Gemcitabine

Primary Outcome Measure

Progression Free Survival (PFS), as Defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. [ Time Frame: 24 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
St. Vincent Anderson Regional HospitalAndersonIndiana46016-
Community Regional Cancer CareIndianapolisIndiana46256-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
IU Health Central Indiana Cancer CenterIndianapolisIndiana46219-
IU Health Ball Memorial Hospital Cancer CenterMuncieIndiana47303-
Community Healthcare SystemMunsterIndiana46321-
HealthPartners InstituteMinneapolisMinnesota55440-
University of Texas Medical Branch at GalvestonGalvestonTexas77555-
University of Virginia Health SystemCharlottesvilleVirginia22908-

Find similar trials in Anderson, IN

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
St. Vincent Anderson Regional Hospital· Anderson, INCommunity Regional Cancer Care· Indianapolis, INIndiana University Melvin and Bren Simon Cancer Center· Indianapolis, INIU Health Central Indiana Cancer Center· Indianapolis, INIU Health Ball Memorial Hospital Cancer Center· Muncie, INCommunity Healthcare System· Munster, IN

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