Submitted by: Rosalytte P. Ronsayro 2015-02-16 00:00:00 Last Updated by: Raymond Val Padua 2018-11-29 10:28:33


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 E-Mail 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 E-Mail 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

1200.217

Unspecified

2015-01-26

0000-00-00

10

5

sites 6302 and 6303 were not able to randomized subjects during end of recruitment period

07 Apr 2015

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. 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

Utilization Utilization Info
No records found.

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