Phase 4
Completed N=25
Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older
Non-Small Cell Lung Cancer · ErbB Receptors
Source: ClinicalTrials.gov NCT02514174 ↗
Enrolled (actual)
25
Serious AEs
40.0%
Results posted
Mar 2020
Primary outcomePrimary: Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib — 32.0 Percentage
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib |
32.0 | — |
| SECONDARY Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher |
8.0 | — |
| SECONDARY Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher |
0.0 | — |
| SECONDARY Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher |
4.0 | — |
| SECONDARY Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher |
8.0 | — |
| SECONDARY Time to First Dose Reduction of Afatinib Caused by Adverse Events |
1.0; 0.7889; 0.7450; 0.6519; 0.6519; 0.6519 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02514174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.