Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
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ClinicalTrials.gov Identifier: NCT02208843 |
Recruitment Status :
Completed
First Posted : August 5, 2014
Results First Posted : December 17, 2018
Last Update Posted : December 17, 2018
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Condition or disease | Intervention/treatment | Phase |
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Carcinoma, Non-Small-Cell Lung | Drug: Afatinib | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | October 2, 2014 |
Actual Primary Completion Date : | May 17, 2017 |
Actual Study Completion Date : | June 13, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Afatinib
Afatinib tablet once daily until progression
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Drug: Afatinib
Afatinib tablet once daily until progression |
- Objective Tumour Response (Complete Response [CR], Partial Response [PR]) as Assessed by the Investigator According to the RECIST Version 1.1 [ Time Frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days ]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
- Progression-free Survival (PFS) as Assessed by the Investigator According to RECIST 1.1. [ Time Frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days ]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.
- Disease Control (CR, PR, Stable Disease [SD]) as Assessed by the Investigator According to RECIST 1.1 [ Time Frame: Post baseline tumour-imaging was performed at every 8 weeks until Week 56 and then every 12 weeks; up to 802 days ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208843

Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Documents provided by Boehringer Ingelheim:
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT02208843 |
Other Study ID Numbers: |
1200.217 2014-001077-14 ( EudraCT Number ) |
First Posted: | August 5, 2014 Key Record Dates |
Results First Posted: | December 17, 2018 |
Last Update Posted: | December 17, 2018 |
Last Verified: | June 2018 |
Carcinoma, Non-Small-Cell Lung Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Afatinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |