Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Recurrence

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Mitogens

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Boehringer Ingelheim

There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.

Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

An Open-label, Single-arm Phase IV Study of Afatinib in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Who Have Poor Performance Status and Whose Tumors Have the Common Epidermal Growth Factor Receptor (EGFR) Mutations, Exon 19 Deletions or Exon 21(L858R) Substitution Mutations

Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.

Percentage of patients with occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher diarrhoea, rash/acne+, stomatitis+ and paronychia+ (+ represents grouped term).

Time to first dose reduction of afatinib caused by Adverse Events (AEs) defined as time from the date of the first administration of afatinib to the first dose reduction of afatinib caused by AEs.

Subject received Giotrif® / Gilotrif® (Afatinib) with starting dose of 30 milligram (mg) orally, once daily until progression or occurrence of intolerable adverse event (AE) or end of trial.

Age, Continuous

Sex: Female, Male

Patients who receive at least one dose of afatinib will be included in the treated set. All data collected from the single patient who received study medication.

This study was stopped prematurely when only 1 patient had received afatinib treatment so it was not possible to draw any conclusion.

Boehringer Ingelheim, Call Center

Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication.

Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib

Patients who receive at least one dose of afatinib will be included in the treated set.All data collected from the single patient who received study medication. All data collected from the single patient who received study medication.

Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)

All data collected from the single patient who received study medication. As none of the AEs led to the dose reduction hence time to first dose reduction is not applicable.

Spots Global Cancer Trial Database for Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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