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

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

An Open Label, Single-arm Phase IV Study to Assess the Efficacy and Safety of Afatinib as Second-line Therapy for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harbouring an EGFR Mutation (Del19 or L858R) Who Have Failed First-line Treatment With Platinum-based Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208843
• Other study ID #: 1200.217
• Secondary ID: 2014-001077-14
• Status: Completed
• Phase: Phase 4
• Start date: October 2, 2014
• Est. completion date: June 13, 2017

Study information

• Verified date: June 2018
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 13, 2017
• Est. primary completion date: May 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Afatinib
Afatinib tablet once daily until progression

Locations

Country	Name	City	State
Egypt	Clinical Research Center, Alexandria University Hospital	Alexandria
Egypt	Kasr Al Ainy Hospital	Cairo
Egypt	National Cancer Institute, Cairo University	Cairo
Malaysia	Nilai Medical Centre	Nilai
Philippines	Baguio General Hospital and Medical Center	Baguio City
Philippines	St. Luke's Medical Center	Taguig
Poland	University Clinical Center, Gdansk	Gdansk
Poland	Specialist Hospital, Szczecin-Zdunowo	Szczecin-Zdunowo
Poland	Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer	Warsaw
Romania	Braila County Emergency Hospital, Medical Oncology	Braila
Romania	Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'	Bucharest
Romania	Sf. Nectarie Oncology Center, Craiova	Craiova
Romania	Regional Oncology Institute of Iasi, Medical Oncology	Iasi
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol	Sremska Kamenica
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Rajavithi Hospital	Bangkok
Thailand	Wattanosoth Hospital	Bangkok
Thailand	Songklanagarind Hospital	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Egypt,  Malaysia,  Philippines,  Poland,  Romania,  Serbia,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.	Progression-free survival (PFS) is the time from treatment start to disease progression (or death if the patient died before progression). PFS as assessed based on investigator review according to the response evaluation criteria in solid tumours (RECIST) version 1.1.	Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Secondary	Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1	As Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), =30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression.	Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days

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