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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]

NCT ID: NCT01003899

Last Updated: 2013-12-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

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.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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afatinib (BIBW 2992)

patient to receive afatinib(BIBW 2992) po QD in an open-label manner

Group Type EXPERIMENTAL

afatinib (BIBW 2992)

Intervention Type DRUG

afatinib (BIBW 2992) po QD

Interventions

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afatinib (BIBW 2992)

afatinib (BIBW 2992) po QD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1200.72.8201 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1200.72.8202 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1200.72.8203 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 24868099 (View on PubMed)

Other Identifiers

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1200.72

Identifier Type: -

Identifier Source: org_study_id