Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older

Carcinoma, Non-Small-Cell Lung Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02514174
• Other study ID #: 1200.209
• Status: Completed
• Phase: Phase 4
• Start date: August 18, 2015
• Est. completion date: April 25, 2019

Study information

• Verified date: March 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 25, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• ErbB Receptors

Intervention

Drug:
• Afatinib
afatinib starting at 30 mg daily dose

Locations

Country	Name	City	State
United States	Pacific Cancer Medical Center, Inc.	Anaheim	California
United States	Montefiore Medical Center	Bronx	New York
United States	City of Hope	Duarte	California
United States	Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.	Fountain Valley	California
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Los Angeles Hematology Oncology Medical Group	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Mayo Clinic-Arizona	Scottsdale	Arizona
United States	Baystate Health D'Amour Center for Cancer Care	Springfield	Massachusetts
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction 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 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).	On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Secondary	Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher	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).	On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Secondary	Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher	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).	On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Secondary	Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher	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).	On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Secondary	Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher	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).	On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Secondary	Time to First Dose Reduction of Afatinib Caused by Adverse Events	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.	On-treatment period, up to 1057 days

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