Description:
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end
of trial. The end of trial is one year after the last patient has entered the study.
Title
- Brief Title: Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
- Official Title: A Single Arm Phase IV Study of Afatinib in Elderly Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Whose Tumors Have Epidermal Growth Factor Receptor (EGFR) Exon 19 Deletions or Exon 21(L858R) Substitution Mutations
Clinical Trial IDs
- ORG STUDY ID:
1200.209
- NCT ID:
NCT02514174
Conditions
- Carcinoma, Non-Small-Cell Lung
- ErbB Receptors
Interventions
| Drug | Synonyms | Arms |
|---|
| Afatinib | | Afatinib |
Purpose
Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end
of trial. The end of trial is one year after the last patient has entered the study.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Afatinib | Experimental | afatinib starting at 30 mg daily dose | |
Eligibility Criteria
Inclusion criteria:
- Pathologically or cytologically confirmed NSCLC Stage IV Cancer (includes
cytologically proven pleural effusion or pericardial effusion) or recurrent disease.
Staging is based on American Joint Committee on Cancer (AJCC) Staging for NSCLC 7th
edition (R12-4710)
- Evidence of common EGFR mutation (Del 19 and/or L858R)
- Age >= 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (R01-0787)
- Further inclusion criteria apply.
Exclusion criteria:
- Prior participation in an afatinib clinical study, even if not assigned to afatinib
treatment
- Prior systemic therapy for metastatic or recurrent NSCLC.
- Concurrent investigational therapy or investigational therapy within 4 weeks of start
of afatinib therapy
- Radiotherapy within 4 weeks prior to start of study treatment, except as follows:
- Palliative radiation to target organs other than chest may be allowed up to 2
weeks prior to study treatment, or
- Single dose palliative treatment for symptomatic metastasis outside above
allowance to be discussed with sponsor prior to enrolling.
- Major surgery within 4 weeks before starting study treatment or scheduled for
surgery during the projected course of the study
- Systemic chemotherapy, biological therapy, immunotherapy or investigational
agents within 5 half-life of the drug or within four weeks prior to the start of
afatinib treatment (if the half-life of the drug is unknown).
- Men, capable of fathering a child, who are unwilling to use adequate contraception
prior to study entry, for the duration of study participation, and for at least 28
days after treatment has ended.
- Further exclusion criteria apply.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 70 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib |
| Time Frame: | On-treatment period + 28 days (residual effect period), up to 1057 + 28 days |
| Safety Issue: | |
| Description: | On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria). |
Secondary Outcome Measures
| Measure: | Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher |
| Time Frame: | On-treatment period + 28 days (residual effect period), up to 1057 + 28 days |
| Safety Issue: | |
| Description: | Percentage of participants with adverse event being diarrhoea of CTCAE grade 3 or higher.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria). |
| Measure: | Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher |
| Time Frame: | On-treatment period + 28 days (residual effect period), up to 1057 + 28 days |
| Safety Issue: | |
| Description: | Percentage of participants with adverse event = rash/acne (grouped term) of CTCAE grade 3 or higher.
MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria). |
| Measure: | Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher |
| Time Frame: | On-treatment period + 28 days (residual effect period), up to 1057 + 28 days |
| Safety Issue: | |
| Description: | Percentage of participants with adverse event = stomatitis (grouped term) of CTCAE grade 3 or higher.
MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria). |
| Measure: | Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher |
| Time Frame: | On-treatment period + 28 days (residual effect period), up to 1057 + 28 days |
| Safety Issue: | |
| Description: | Percentage of participants with adverse event = paronychia (grouped term) of CTCAE grade 3 or higher.
MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria). |
| Measure: | Time to First Dose Reduction of Afatinib Caused by Adverse Events |
| Time Frame: | On-treatment period, up to 1057 days |
| Safety Issue: | |
| Description: | Time to first dose reduction of afatinib caused by adverse events is defined as time from the date of the first administration of afatinib to the date of first dose reduction of afatinib caused by adverse events. Participants without AEs leading to dose reduction were censored at date of last intake of afatinib.
On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent from study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
The cumulative probability of no dose reduction at the respective time point is given by the Kaplan-Meier estimate at the respective time point based on time to first dose reduction of afatinib caused by adverse events. |
Details
| Phase: | Phase 4 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Boehringer Ingelheim |
Last Updated
March 30, 2020
