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An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

NCT ID: NCT01932229

Last Updated: 2013-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Brief Summary

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Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.

Detailed Description

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Conditions

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NSCLC

Keywords

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Advanced NSCLC EGFR mutation TKIs Tyrosine Kinase Inhibitors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Afatinib treatment

Group Type EXPERIMENTAL

Afatinib treatment

Intervention Type DRUG

Interventions

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Afatinib treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Advanced NSCLC
* EGFR mutation or six months or longer benefit from EGFR TKIs
* Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
* Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.

Exclusion Criteria

* Inability to take oral drugs
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sheba Medical Center

Ramat Gat, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Jair Bar, MD-PhD

Role: CONTACT

Phone: +972-3-530-7096

Dina Vornstein, B.A.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Dina Vornstein

Role: primary

Other Identifiers

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SHEBA-12-9547-JB-CTIL

Identifier Type: -

Identifier Source: org_study_id