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]

Boehringer Ingelheim43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

afatinib (BIBW 2992)DRUG

afatinib (BIBW 2992) po QD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer\[NSCLC\] 2. Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen 3. A known wild-type EGFR status 4. Patients 18 years of age or older Exclusion criteria: 1. More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease 2. Prior treatment with EGFR targeting small molecules or antibodies 3. Radiotherapy or surgery within 4 weeks prior to study entry 4. Active brain metastasis 5. Known pre-existing interstitial lung disease 6. History or presence of clinically relevant cardiovascular abnormalities 7. Cardiac left ventricular function with resting ejection fraction of less than 50% 8. Absolute neutrophil count\[ANC\] \< 1,500/mm3 9. Platelet count \<100,000/mm3 10. Creatinine clearance\<60ml/min or serum creatinine \>1.5 times upper limit of normal 11. Women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial 12. Pregnancy or breast-feeding

Locations (3)

1200.72.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

1200.72.8202 Boehringer Ingelheim Investigational Site

Seoul, South Korea

1200.72.8203 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

Percentage of Participants With Best Objective Response

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