Trial of BIBW 2992 (Afatinib) + Cetuximab in Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
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.