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Withdrawn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

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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