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

NCT02208843 | Completed Phase 4 Results

• 2 other identifiers: 1200.2172014-001077-14
• Study Type: interventional
• Target: 60
• Locations: 7 countries
• Sites: 21

Brief Summary

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1

  As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions

  Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days

Secondary Outcomes (2)

• Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.

  Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days

• Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1

  Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days

Study Arms (1)

Afatinib

EXPERIMENTAL

Afatinib tablet once daily until progression

Drug: Afatinib

Interventions

Afatinib DRUG

Afatinib tablet once daily until progression

Afatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
• Measureable disease according to RECIST 1.1.
• Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
• Adequate organ function.

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (21)

Clinical Research Center, Alexandria University Hospital

Alexandria, 21131, Egypt

Location

National Cancer Institute, Cairo University

Cairo, 11796, Egypt

Location

Kasr Al Ainy Hospital

Cairo, 12311, Egypt

Location

Nilai Medical Centre

Kampung Baharu Nilai, 71800, Malaysia

Location

Baguio General Hospital and Medical Center

Baguio City, 2600, Philippines

Location

St. Luke's Medical Center

City of Taguig, 1634, Philippines

Location

University Clinical Center, Gdansk

Gdansk, 80-952, Poland

Location

Specialist Hospital, Szczecin-Zdunowo

Szczecin-Zdunowo, 70-891, Poland

Location

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

Warsaw, 02-781, Poland

Location

Braila County Emergency Hospital, Medical Oncology

Brăila, 810303, Romania

Location

Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'

Bucharest, 022328, Romania

Location

Sf. Nectarie Oncology Center, Craiova

Craiova, 200347, Romania

Location

Regional Oncology Institute of Iasi, Medical Oncology

Iași, 700483, Romania

Location

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

Belgrade, 11000, Serbia

Location

Clinical Center of Serbia

Belgrade, 11129, Serbia

Location

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

Kamenitz, 21204, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Wattanosoth Hospital

Bangkok, 10310, Thailand

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 5, 2014
• Study Start: October 2, 2014
• Primary Completion: May 17, 2017
• Study Completion: June 13, 2017
• Last Updated: December 17, 2018
• Results First Posted: December 17, 2018

Record last verified: 2018-06

Locations

MY (1); PH (2); SE (4); EG (3); RO (4); TH (4); PL (3)