|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02208843 |
|
Date of registration:
|
04/08/2014 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
|
|
Scientific 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 |
|
Date of first enrolment:
|
October 2, 2014 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02208843 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Egypt
|
Malaysia
|
Philippines
|
Poland
|
Romania
|
Serbia
|
Thailand
| |
|
Contacts
|
|
Name:
|
Boehringer Ingelheim |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Boehringer Ingelheim |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Carcinoma, Non-Small-Cell Lung
|
|
Intervention(s)
|
|
Drug: Afatinib
|
|
Primary Outcome(s)
|
|
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]
|
|
Secondary Outcome(s)
|
|
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]
|
|
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]
|
|
Secondary ID(s)
|
|
2014-001077-14
|
|
1200.217
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|