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]

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: afatinib (BIBW 2992)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Pathologically confirmed stage IIIB/IV adenocarcinoma in non-small cell lung cancer[NSCLC] Progressive disease following a second-line cytotoxic chemotherapy including at least one platinum-containing regimen A known wild-type EGFR status Patients 18 years of age or older Exclusion criteria: More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic disease Prior treatment with EGFR targeting small molecules or antibodies Radiotherapy or surgery within 4 weeks prior to study entry Active brain metastasis Known pre-existing interstitial lung disease History or presence of clinically relevant cardiovascular abnormalities Cardiac left ventricular function with resting ejection fraction of less than 50% Absolute neutrophil count[ANC] < 1,500/mm3 Platelet count <100,000/mm3 Creatinine clearance<60ml/min or serum creatinine >1.5 times upper limit of normal 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 Pregnancy or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: afatinib (BIBW 2992)<br>patient to receive afatinib(BIBW 2992) po QD in an open-label manner | Drug: afatinib (BIBW 2992)<br>* afatinib (BIBW 2992) po QD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline till progression or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Disease Control (DC) | Percentage of participants with objective response or stable disease (SD) as determined by RECIST version 1.1. | Baseline till progression or death | 
| Progression Free Survival (PFS) Time | 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 | Baseline till end of study or death | 
| Duration of Disease Control (DC) | Duration of diesease control (DC) (objective response or stable disease (SD) as determined by RECIST version 1.1). | Baseline till progression or death | 
| Time to OR | 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. | Baseline till progression or death | 
| Duration of OR | 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. | Baseline till progression or death |