Phase 2 Trial of Durvalumab With or Without Bavituximab in Patients With Previously Treated Metastatic Non-small-cell Lung Cancer

Sponsor
Peregrine Pharmaceuticals
Study ID
NCT02673814
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • durvalumab — BIOLOGICAL
  • bavituximab — BIOLOGICAL

Study Details

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to durvalumab will improve the results of the treatment for non-small-cell lung cancer.

Key Dates

First listed
Feb 4, 2016
Start date
Feb 29, 2016
Status verified
Jul 2016
Primary completion
Apr 30, 2017
Completion
Apr 30, 2018

Study Design

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

Arms

  • Experimental: Arm A (durvalumab)
    10 mg/kg durvalumab alone every two weeks
  • Experimental: Arm B (bavituximab + durvalumab)
    3 mg/kg bavituximab weekly in combination with 10 mg/kg durvalumab every two weeks
  • Experimental: Arm C (bavituximab + durvalumab)
    3 mg/kg bavituximab in combination with 10 mg/kg durvalumab both every two weeks

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 24 months ]

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