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Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

NCT ID: NCT02208843

Last Updated: 2018-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-02

Study Completion Date

2017-06-13

Brief Summary

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The objectives of this single-arm, open-label trial are to assess the efficacy and safety of afatinib as second line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation who have failed first-line platinum-based chemotherapy and to demonstrate that the efficacy and safety are comparable to the results seen in previous trials.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

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

Afatinib tablet once daily until progression

Group Type EXPERIMENTAL

Afatinib

Intervention Type DRUG

Afatinib tablet once daily until progression

Interventions

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Afatinib

Afatinib tablet once daily until progression

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
2. Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
3. Measureable disease according to RECIST 1.1.
4. Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
5. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
6. Adequate organ function.

Exclusion Criteria

1. More than one line of prior therapy for disease.
2. Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
3. Previous treatment with any EGFR targeting Tyrosine Kinase Inhibitor (TKI) or antibody.
4. Known pre-existing interstitial lung disease.
Minimum Eligible Age

18 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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Clinical Research Center, Alexandria University Hospital

Alexandria, , Egypt

Site Status

National Cancer Institute, Cairo University

Cairo, , Egypt

Site Status

Kasr Al Ainy Hospital

Cairo, , Egypt

Site Status

Nilai Medical Centre

Kampung Baharu Nilai, , Malaysia

Site Status

Baguio General Hospital and Medical Center

Baguio City, , Philippines

Site Status

St. Luke's Medical Center

City of Taguig, , Philippines

Site Status

University Clinical Center, Gdansk

Gdansk, , Poland

Site Status

Specialist Hospital, Szczecin-Zdunowo

Szczecin-Zdunowo, , Poland

Site Status

Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer

Warsaw, , Poland

Site Status

Braila County Emergency Hospital, Medical Oncology

Brăila, , Romania

Site Status

Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'

Bucharest, , Romania

Site Status

Sf. Nectarie Oncology Center, Craiova

Craiova, , Romania

Site Status

Regional Oncology Institute of Iasi, Medical Oncology

Iași, , Romania

Site Status

Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.

Belgrade, , Serbia

Site Status

Clinical Center of Serbia

Belgrade, , Serbia

Site Status

Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol

Kamenitz, , Serbia

Site Status

Clinical Center Kragujevac

Kragujevac, , Serbia

Site Status

Wattanosoth Hospital

Bangkok, , Thailand

Site Status

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Site Status

Rajavithi Hospital

Bangkok, , Thailand

Site Status

Songklanagarind Hospital

Songkhla, , Thailand

Site Status

Countries

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Egypt Malaysia Philippines Poland Romania Serbia Thailand

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2014-001077-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1200.217

Identifier Type: -

Identifier Source: org_study_id