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Afatinib

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patient to receive afatinib(BIBW 2992) po QD in an open-label manner

afatinib (BIBW 2992)

Boehringer Ingelheim

To explore the efficacy of BIBW 2992 defined by the objective response rate (Complete Response, Partial Response) as determined by Response Evaluation Criteria in Solid Tumours\[RECIST\] 1.1 in the patients with advanced (stage IIIB or IV) adenocarcinoma of the lung harbouring wild-type EGFR.

A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]

A Phase II Trial of BIBW 2992 as a Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type EGFR

Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (version 1.1).

Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1.

PFS time is defined as time from start of treatment to the earliest of progression (RECIST version 1.1), clinical progression (investigator), start of new anti-cancer treatment or death

Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1).

The time to objective response (OR) was the duration from the first treatment to the time when the measurement criteria for CR and/or PR were met according to RECIST 1.1 criteria.

Duration of OR was measured from the time the criteria for CR or PR (whichever was documented first) were first met until the first date that progressive disease or death was objectively documented.

Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal

Afatinib 40 mg

Age, Continuous

Sex: Female, Male

Treated Set (TS) consists of all patients treated with at least one dose of study drug.

Boehringer Ingelheim Call Center

FAS (Full Analysis Set). The FAS consisted of all treated patients, excluding any patients found not be EGFR mutation negative according to central laboratory testing.

Percentage of Participants With Best Objective Response

Percentage of Participants With Disease Control (DC)

Progression Free Survival (PFS) Time

Duration of Disease Control (DC)

Time to OR

Duration of OR

Overall Study

All patients will be given daily oral afatinib (BIBW 2992) administered every 28 days until disease progression/toxicity/clinician decision to stop. Starting dose is 40mg. 30mg and 20mg will be administered according to protocol dose modification requirements following toxicity.

Afatinib (BIBW 2992)

Sanjay Popat, BSc MBBS MRCP PhD

The purpose of this study is to examine the efficacy and safety of using afatinib (BIBW 2992) to treat non-small cell lung cancer patients considered unfit for chemotherapy and have either suspected or confirmed Epidermal Growth Factor Receptor (EGFR) mutation.

Lung cancer is most common cause of death from cancer, of which non-small cell lung cancer (NSCLC) accounts for \~80% of all cases with most patients presenting with advanced disease. Patients medically unfit to receive radical or platinum-doublet palliative systemic therapy, because of poor performance status or comorbidity, account for at least 45% of newly diagnosed cases and have poor survival. Many oncologists have interpreted single-agent chemotherapy data as not clinically meaningful when balanced against toxicities, non-significant improvements in quality of life and comorbidity. Hence, in the UK, this group of patients are predominantly treated by best-supportive care (BSC).

This study aims to examine the efficacy and safety of using afatinib (BIBW 2992), an irreversible second generation EGFR inhibitor, in patients with non-small cell lung cancer, who are considered unfit for chemotherapy and have either suspected or confirmed Epidermal Growth Factor Receptor (EGFR) mutation.

Suspected EGFR mutant patients will have clinical characteristics likely to harbour the EGFR mutation (adenocarcinoma sub type and ex or never smokers) with EGFR genotype unknown either due to no tissue suitable for genotyping or failed genotype.

There has been only one small prospective study of medically unfit patients with EGFR mutation, but it demonstrated good efficacy with a TKI17. This phase II study of East Asian patients (n=30) with performance status 2-4 and treated with gefitinib demonstrated a rapid improvement in performance status at 1 month, an overall response rate of 66% and median survival of 17.8 months. Whilst gefitinib is licensed for EGFR mutant NSCLC, no prospective studies have yet been performed on medically unfit patients from Western countries. Despite dramatic initial responses, EGFR mutant NSCLC patients treated with gefitinib/erlotinib ultimately relapse. In \~50% of cases this is due to the gefitinib/erlotinib-resistant T790M genotype acquired through either secondary somatic mutation or clonal expansion. There is therefore a need to improve the outcomes of medically unfit patients with suspected EGFR mutation, who would otherwise be treated with best supportive care, and in proven EGFR mutation cases by using an effective EGFR-directed therapy that inhibits EGFRT790M.

Prospective data on medically unfit Western NSCLC patients with EGFR mutation are required to assess the efficacy of EGFR-TKIs. Additionally, given that 50% of such patients will become TKI-resistant through EGFRT790M, new therapies are required to overcome this resistance mechanism.

Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients

Trial of Afatinib (BIBW 2992) in Suspected or Confirmed Mutant EGFR Lung Cancer Patients Unfit for Chemotherapy

Progression free survival will be determined by measurement of tumour size using RECIST version 1.1 at progression or date of patient death.

For each type of adverse event, the maximum toxicity grade will be obtained for each patient using CTCAE version 4.0 to closely monitor tolerability to BIBW 2992. Focus will be on those with a grade 3 or 4 BIBW 2992 related toxicities. The proportion of patients with any grade 3 or 4 event will also be examined.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]	NCT01003899	Carcinoma, Non-...	afatinib (BIBW ...	18 Years - 80 Years	Boehringer Ingelheim
Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients	NCT01415011	Carcinoma, Non-...	Afatinib (BIBW ...	18 Years -	University College, London
A Phase II Trial of Afatinib(BIBW 2992) in Third-line Treatment for Patients With Stage IIIB/IV Adenocarcinoma of the Lung Harbouring Wild-type Epidermal Growth Factor Receptor[EGFR]	NCT01003899	Carcinoma, Non-...	afatinib (BIBW ...	18 Years - 80 Years	Boehringer Ingelheim
Efficacy and Safety Study of Afatinib to Treat Lung Cancer Patients	NCT01415011	Carcinoma, Non-...	Afatinib (BIBW ...	18 Years -	University College, London

Spots Global Cancer Trial Database for afatinib (bibw 2992)