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

NCT03041181 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-07-11

Study results available
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Summary

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

Conditions

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

Interventions

DRUG

Docetaxel

Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)

DRUG

Nivolumab

Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle)

DRUG

Gemcitabine

Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)

DRUG

Pemetrexed

Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)

Sponsors & Collaborators

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Nasser Hanna, M.D.

    lead OTHER

Principal Investigators

  • Nasser Hanna, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-27
Primary Completion
2019-05-23
Completion
2019-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03041181 on ClinicalTrials.gov