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Phase III Trial BI 695502 Plus Chemotherapy vs. Avastin® Plus Chemotherapy in Patients With Lung Cancer

NCT02272413 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2020-01-13

Study results available
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Summary

The objective of this phase III trial is to establish statistical equivalence in terms of efficacy (best overall response rate \[ORR\], proportion of patients with complete response \[CR\] plus partial response \[PR\]) until 18 weeks of first-line treatment with BI 695502 plus chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with either BI 695502 or Avastin®.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

BI 695502

DRUG

Avastin

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-08
Primary Completion
2017-06-30
Completion
2018-11-16

Countries

  • United States
  • Argentina
  • Brazil
  • Bulgaria
  • Chile
  • Croatia
  • Egypt
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Philippines
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02272413 on ClinicalTrials.gov