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Proposal 1475

Title of the Proposed Research

Predicting safety and efficacy of afatinib treatment of NSCLC

Lead Researcher

Assoc/Prof Michael Sorich


Flinders Centre for Innovation in Cancer
Flinders University
Adelaide, Australia

Funding Source

Partially supported by a Project Grant of the National Health and Medical Research Council of Australia.

Potential Conflicts of Interest


Data Sharing Agreement Date

8 August 2016

Lay Summary

Lung cancer is one of the most common and difficult to treat forms of cancer. Afatinib is one of the main cancer medicines that may be used by individuals with lung cancer. It has been found to prolong survival but its use may also lead to patients experience adverse effects such as diarrhoea and skin reactions. There is also considerable inter-individual variability – that is, some people gain significant benefit and others appear to gain little or no benefit, some patients have severe adverse effects and others have little or no toxicity. Being able to predict, in advance, individuals at greatest risk of harms and greatest risk of treatment failure may allow doctors and patients to make better treatment decisions.

This project primarily aims to improve understanding of and the ability to predict the risk of benefits and harms from using afatinib for treatment of lung cancer. Using data from completed clinical trials, patient characteristics which are associated with benefit and harms from afatinib will be identified and where possible prediction models will be developed to make the best predictions possible for new patients being considered for treatment for afatinib and for patients early in the treatment with afatinib. Any improved understanding of risk factors (and prediction models) of benefit and harms with afatinib will be communicated internationally in medical publications to inform clinicians treating with afatinib so that they can better explain the risks to patients considering the use of afatinib.

Study Data Provided

Study BI-1200.23: BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
Study BI-1200.33: LUX-Lung 4: BIBW 2992 (Afatinib) Phase I Trial in Advanced Non Small Cell Lung Cancer Patients & Phase II Trial in Non Small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib
Study BI-1200.23: LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations
Study BI-1200.32: BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
Study BI-1200.34: BIBW 2992 (Afatinib) vs Gemcitabine-cisplatin in 1st Line Non-small Cell Lung Cancer (NSCLC)
Study BI-1200.41: Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients
Study BI-1200.40: BIBW2992 (Afatinib) in Advanced (EGFR-FISH +) NSCLC (Non Small Cell Lung Cancer) Patients

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.