Clinical trial NCT02208843: Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1
timeFrame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Secondary outcomes:
measure: Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1.
timeFrame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
measure: Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1
timeFrame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Clinical Research Center, Alexandria University Hospital
city: Cairo
country: Egypt
facility: National Cancer Institute, Cairo University
city: Cairo
country: Egypt
facility: Kasr Al Ainy Hospital
city: Nilai
country: Malaysia
facility: Nilai Medical Centre
city: Baguio City
country: Philippines
facility: Baguio General Hospital and Medical Center
city: Taguig
country: Philippines
facility: St. Luke's Medical Center
city: Gdansk
country: Poland
facility: University Clinical Center, Gdansk
city: Szczecin-Zdunowo
country: Poland
facility: Specialist Hospital, Szczecin-Zdunowo
city: Warsaw
country: Poland
facility: Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer
city: Braila
country: Romania
facility: Braila County Emergency Hospital, Medical Oncology
city: Bucharest
country: Romania
facility: Institute of Oncology 'Prof. Dr. Alexandru Trestioreanu'
city: Craiova
country: Romania
facility: Sf. Nectarie Oncology Center, Craiova
city: Iasi
country: Romania
facility: Regional Oncology Institute of Iasi, Medical Oncology
city: Belgrade
country: Serbia
facility: Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco.
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Inst. for Pulm. Diseases of Vojvodine, Clinic f. Pulm. Oncol
city: Bangkok
country: Thailand
facility: Wattanosoth Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: