Clinical trial NCT01003899: 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]
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-10-29
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Best Objective Response
timeFrame: Baseline till progression or death
Secondary outcomes:
measure: Percentage of Participants With Disease Control (DC)
timeFrame: Baseline till progression or death
measure: Progression Free Survival (PFS) Time
timeFrame: Baseline till end of study or death
measure: Duration of Disease Control (DC)
timeFrame: Baseline till progression or death
measure: Time to OR
timeFrame: Baseline till progression or death
measure: Duration of OR
timeFrame: Baseline till progression or death
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 1200.72.8201 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1200.72.8202 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1200.72.8203 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Ahn MJ, Kim SW, Cho BC, Ahn JS, Lee DH, Sun JM, Massey D, Kim M, Shi Y, Park K. Phase II study of Afatinib as third-line treatment for patients in Korea with stage IIIB/IV non-small cell lung cancer harboring wild-type EGFR. Oncologist. 2014 Jul;19(7):702-3. doi: 10.1634/theoncologist.2013-0419. Epub 2014 May 27.