Afatinib as second line therapy for lung cancer with Epidermal Growth Factor Receptor mutation.
PHRR150225-000956
1200.217
2014-CT0253
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
This is a single-arm open-label phase IV trial for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring a common EGFR mutation.
| Regime | Classification | Priority |
|---|---|---|
| 2010 - 2016 | Health Technology Development | Drug Discovery and Development |
| Start Date | Duration in Months | Target Completion Date | Actual Completion Date |
|---|---|---|---|
| 2015-04-07 | 26 | 2017-06-07 | 2017-04-26 |
Completed
| Institution | Classification | Region | LTO # |
|---|---|---|---|
| Boehringer Ingelheim Singapore, Pte. Ltd. | Private Business | Singapore | CDRR-NCR-S-5 |
| Institution | Region |
|---|---|
| Boehringer Ingelheim Singapore, Pte. Ltd. | Singapore |
| Name | Institution and Institution Address | |
|---|---|---|
| Dr. Greta Cortez | MEDROPUSEASKRegistry.SG@boehringer-ingelheim.com | Boehringer Ingelheim Phil. Inc. 23rd Floor Citibank Tower, 8741 Paseo de Roxas, Makati City 1227 |
| Name | Institution and Institution Address | |
|---|---|---|
| Dr. Greta Cortez | MEDROPUSEASKRegistry.SG@boehringer-ingelheim.com | Boehringer Ingelheim Phil. Inc. 23rd Floor Citibank Tower, 8741 Paseo de Roxas, Makati City 1227 |
| Name | Expertise | Affiliation |
|---|---|---|
| Jasmin Igama, MD | Medical Oncology and Adult Hematology | Baguio General Hospital and Medical Center |
| Joseph Parra, MD | Medical Oncology | St. Luke's Medical Center - Global City |
| Priscilla B. Caguioa, MD | Medical Oncology and Hematology | University of Santo Tomas Hospital |
| Project Location | Institutional Ethics Review Board |
|---|---|
| Baguio General Hospital and Medical Center | Baguio General Hospital and Medical Center Ethics Review Committee |
| St. Luke's Medical Center - Global City | N/A |
| University of Santo Tomas Hospital | University of Santo Tomas Hospital Institutional Review Board |
Locally advanced or metastatic non-small cell lung cancer harbouring an EGFR mutation who have failed first-line treatment with platinum-based chemotherapy
The primary endpoint will be objective tumour response (Complete response , Partial Response) according to RECIST 1.1
The secondary endpoints are;
Progression free survival according to RECIST 1.1.
Disease control (CompleteResponse, PartialResponse, Stable Disease ) according to RECIST1.1.
Completed
- Egypt
- Malaysia
- Philippines
- Poland
- Romania
- Serbia
- Thailand
Clinical Trial
Unspecified
2015-01-26
0000-00-00
10
5
sites 6302 and 6303 were not able to randomized subjects during end of recruitment period
2015-04-07
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.
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. Age >18 years.
6. Eastern Cooperative Oncology Group performance score of 0 or 1.
7. Adequate organ function, defined as all of the following:
- Absolute neutrophil count > 1500 / mm3.
- Platelet count >75,000 / mm3.
- Estimated creatinine clearance > 45ml / min.
- Total Bilirubin < 1.5 times upper limit of institution normal.
- Aspartate amino transferase and alanine amino transferase < three times the upper limit of institution normal (if related to liver metastases < five times ULN).
8. Recovered from any previous therapy-related toxicity to ≤CTCAE Grade 1 at study entry (except for alopecia and stable sensory neuropathy which must be ≤CTCAE Grade 2).
9. Life expectancy of at least three months.
10. Written informed consent that is consistent with ICH-GCP guidelines.
Exclusion criteria
1. More than one line of prior therapy for disease.
o Radiotherapy alone is not counted as a line of therapy.
o Radiosensitisers and/or intrapleural administration of anti-cancer agents are not counted as a line of therapy.
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 TKI or antibody.
4. Chemotherapy, biological therapy or investigational agents within three weeks prior to the start of study treatment.
5. Hormonal treatment within two weeks prior to start of study treatment.
6. Radiotherapy within 4 weeks prior to study treatment, except as follows:
i.) Palliative radiation to target organs other than chest is allowed up to 2 weeks prior to study treatment.
ii.) Single dose palliative treatment for symptomatic metastasis which is outside the above allowance may be allowed but must be discussed with sponsor prior to enrolling.
7. Major surgery within 4 weeks before starting study treatment or surgery scheduled during the projected course of the study.
8. Known hypersensitivity to afatinib or the excipients of afatinib.
9. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3,
Interventional
Afatinib
20, 30 and 40mg film-coated tablets
None
Non-randomized
Open Label
Unspecified
Single Arm
This trial is being conducted at the request of the European Medicines Agency (EMA) as a condition of their favourable approval of afatinib for treatment of EGFR TKI-naïve patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutation(s).
Phase IV