Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Paclitaxel

Albumin-Bound Paclitaxel

Afatinib

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

patient to receive tablets of BIBW 2992 once a day, starting at high dose until progression of the disease

patient whose disease progressed on treatment with BIBW 2992 monotherapy to receive tablet of BIBW 2992 once a day in combination with i.v. paclitaxel 3 weekly

BIBW2992

tablet BIBW 2992 in combination with i.v. paclitaxel 3 weekly

BIBW2992 + paclitaxel

Boehringer Ingelheim

The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by the RECIST criteria, in patients with advanced NSCLC Stage IIIB or IV whose tumours harbour activating mutations within exon 18 to exon 21 of the EGFR receptor, in patients with mutations in the HER2/neu receptor and in patients with EGFR FISH positive tumours with no EGFR mutations.

Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients

A Phase II Single-arm Trial of BIBW 2992 in Demographically and Genotypically Selected NSCLC

Percentage of participants with best objective response: confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.0.

Percentage of participants with OR or stable disease (SD) as determined by RECIST version 1.0.

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

Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 15, 29 and 57 (Cpre,ss,15, Cpre,ss,29 and Cpre,ss,57)

Afatinib 50mg film coated tablets were administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)

Afatinib 50mg

Age, Continuous

Sex: Female, Male

Boehringer Ingelheim Call Center

Treated set (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.

Percentage of Participants With Best Objective Response

Percentage of Participants With Disease Control (DC)

Progression Free Survival (PFS) Time

Cpre,ss,15 (N=13)

Cpre,ss,29 (N=12)

Cpre,ss,57 (N=5)

Patients with no data available for the relevant parameter and dose were excluded from analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients	NCT00730925	Carcinoma, Non-...	BIBW2992 BIBW2992 + pacl...	18 Years -	Boehringer Ingelheim
Single-arm Trial of BIBW 2992 (Afatinib) in Demographically and Genotypically Selected NSCLC Patients	NCT00730925	Carcinoma, Non-...	BIBW2992 BIBW2992 + pacl...	18 Years -	Boehringer Ingelheim

Spots Global Cancer Trial Database for bibw2992 + paclitaxel