Therapy Finder Advisor

Ravi Salgia MD PhD
Director of the Thoracic Oncology Program
Professor, University of Chicago

Learn the Science Behind This Tool

Science and the Lung Cancer Molecular Disease Model

Afatinib may be effective in patients not responding to standard therapy

What's promising about afatinib?

Afatinib (marketing name Tomtovok, also called BIBW 2992) is a medication for lung cancer patients for whom standard treatments (such as Tarceva or Iressa) have stopped working. It shrinks tumors in these patients. After treatment cancer may come back though it takes longer than normal. Afatinib is part of a group of drugs called second generation tyrosine kinase inhibitor (TKI) and is being tested by Boehringer Ingelheim.

What are its side effects?

Common side effects of afatinib include diarrhea, nausea, vomiting, fatigue, and skin rash, none of which are severe or unmanageable.

How can I get access to afatinib?

Afatinib is not yet approved by the FDA which means that your doctor will not be able to prescribe it for you. It is currently being tested in phase III clinical trials for patients with several cancers including non small cell lung cancer, breast cancer, head and neck cancer, glioblastoma, and colorectal cancers. You can get access to this drug by enrolling in one of these clinical trials. Clinical trials that use afatinib are listed below and you can learn about them by clicking on individual trials.

Summary

Name(s)	Target	Manufacturer	Status
Afatinib, Tomtovok, BIBW2992		Boehringer Ingelheim	In phase 3 clinical trials for NSCLC and phase 2 clinical trials for various cancers including: breast cancer, glioma, and colorectal cancer

Clinical Trials

Trial	Status	Phase
BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) Patients [NCT00796549]	Active, not recruiting	Phase 2
BIBW 2992 (Afatinib) as a Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR] [NCT01003899]	Completed	Phase 2
Understanding Mechanisms of Acquired Resistance to BIBW2992 [NCT01074177]	Recruiting	Phase 2
Trial Exploring Afatinib (BIBW 2992) + Paclitaxel (Part A), Afatinib + Paclitaxel + Bevacizumab (Part B), Afatinib + Carboplatin (Part C) and Afatinib+ Paclitaxel +Carboplatin(Part D) in Patients With Advanced Solid Tumours [NCT00809133]	Recruiting	Phase 1
BIBW 2992 (Afatinib) in Combination With Pemetrexed in Advanced Solid Tumours [NCT01169675]	Recruiting	Phase 1
LUX-Lung 5: BIBW 2992 (Afatinib) Plus Weekly Paclitaxel Versus Investigator's Choice of Single Agent Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib [NCT01085136]	Active, not recruiting	Phase 3
A Phase I Dose Escalation Trial of Afanitib Plus Gemcitabine or Afatinib Plus Docetaxel [NCT01251653]	Recruiting	Phase 1
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation [NCT00949650]	Active, not recruiting	Phase 3
Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients [NCT00730925]	Completed	Phase 2
Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation and/or Disease Progression Following Prior Erlotinib (Tarceva®) [NCT00993499]	Recruiting	Phase 1
BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC) [NCT01121393]	Active, not recruiting	Phase 3
An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 (Volasertib)in Combination With Oral BIBW 2992 (Afatinib) in Patients With Advanced Solid Tumours [NCT01206816]	Recruiting	Phase 1
Trial of BIBW 2992 (Afatinib) + Cetuximab in Non-Small Cell Lung Cancer [NCT01090011]	Recruiting	Phase 1

Publication	Reference
Monoclonal antibodies against EGFR in non-small cell lung cancer.	Pirker Robert, Crit. Rev. Oncol. Hematol. Oct 2011;80(1):1-9.
Phase I trial of the irreversible EGFR and HER2 kinase inhibitor BIBW 2992 in patients with advanced solid tumors.	Yap Timothy A, J. Clin. Oncol. Sep 2010;28(25):3965-72.