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BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation

NCT00949650 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2018-04-06

Study results available
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Summary

This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma

Interventions

DRUG

Pemetrexed

Pemetrexed IV given once every 3 weeks for up to 6 cycles

DRUG

BIBW 2992

BIBW 2992 once daily until progression

DRUG

Cisplatin

Cisplatin IV given once every 3 weeks for up to 6 cycles

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-14
Primary Completion
2012-02-09
Completion
2017-03-16

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Ireland
  • Italy
  • Japan
  • Malaysia
  • Peru
  • Philippines
  • Romania
  • Russia
  • South Korea
  • Taiwan
  • Thailand
  • Ukraine
  • United Kingdom

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 NCT00949650 on ClinicalTrials.gov