This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatment afatinib
Phase phase 4
Targets EGFR, HER, HER2, HER4
Sponsor Boehringer Ingelheim
Start date October 2014
End date December 2016
Trial size 60 participants
Trial identifier NCT02208843, 1200.217, 2014-001077-14


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Afatinib tablet once daily until progression
Afatinib tablet once daily until progression

Primary Outcomes

Objective tumour response (Complete response (CR), Partial Response (PR)) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
time frame: 24 weeks

Secondary Outcomes

Progression free survival (PFS) according to RECIST 1.1
time frame: 33 months
Disease control (CR, PR, Stable Disease (SD)) according to RECIST 1.1
time frame: 33 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.