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A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label

NCT02318368 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-10-22

Study results available
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Summary

Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Conditions

Interventions

DRUG

Ficlatuzumab

DRUG

Erlotinib

DRUG

placebo

Sponsors & Collaborators

  • Biodesix, Inc.

    collaborator INDUSTRY

  • AVEO Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael N Needle, MD · AVEO Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States
  • Australia
  • Hong Kong
  • Italy
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02318368 on ClinicalTrials.gov