MedTrace Logo

Trial of BIBW 2992 (Afatinib) + Cetuximab in Non-Small Cell Lung Cancer

NCT01090011 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2015-10-02

Study results available
· View outcomes & findings →

Summary

The primary objective of this trial is to determine the maximum tolerated dose (MTD) and recommended Phase II doses for the combination of BIBW 2992 and cetuximab in patients with non-small cell lung cancer and acquired resistance to erlotinib or gefitinib.

Overall safety, pharmacokinetics and anti-tumor activity for the combination of BIBW 2992 and cetuximab in patients with non-small cell lung cancer and acquired resistance to erlotinib, gefitinib or BIBW 2992 will be evaluated as secondary objectives.

Initially a standard, 3+3 dose escalation will be performed to determine the MTD of BIBW 2992 when administered together with cetuximab in patients with advanced non small cell lung cancer and acquired resistance to erlotinib or gefitinib.

Subsequently, the preliminary efficacy and safety of the identified MTD of cetuximab administered with BIBW 2992 will be explored in a combo arm via a further expansion of MTD cohort up to a total of 140 EGFR mutation positive NSCLC with acquired resistance to erlotinib/gefitinib.

Furthermore, the safety and preliminary anti-tumor activity of the combination therapy in EGFR mutant NSCLC patients who developed acquired resistance (AR) to BIBW 2992, will be assessed in a sequential arm. The sequential arm will use a two-stage design with an early stopping rule after 12 patients with acquired resistance to BIBW 2992 have received up to 5 courses of BIBW 2992 plus cetuximab. If no responses are seen in 12 patients during 5 courses of combination therapy, accrual in the sequential arm will stop. If 1 or more responses are observed, the sequential arm will expand up to about 40 patients.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Cetuximab

BIBW 2992 medium dose plus high dose level of cetuximab

DRUG

Cetuximab

BIBW 2992 medium dose monotherapy, upon progression, cetuximab high dose is added

DRUG

BIBW 2992

BIBW 2992 medium dose plus high dose level of cetuximab

DRUG

BIBW 2992

BIBW 2992 medium dose monotherapy, upon progression, cetuximab high dose is added

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-01-31
Completion
2014-08-31

Countries

  • United States
  • Netherlands

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 NCT01090011 on ClinicalTrials.gov