NCT02044380|CompletedPhase 3Results

Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations

An Open Label Trial of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

1200.48

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJan 2014

StartedMar 2014

CompletionFeb 2016

Brief Summary

The main aim of this study is to evaluate the safety and tolerability of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring Epidermal Growth Factor Receptor (EGFR) mutation(s) and have never been treated with an EGFR-Tyrosine Kinase Inhibitor (TKI)

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Mar 2014

Geographic Reach

1 country

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

January 22, 2014

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed

1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

March 31, 2017

Completed

Last Updated

March 31, 2017

Status Verified

February 1, 2017

Enrollment Period

1.9 years

First QC Date

January 22, 2014

Results QC Date

February 15, 2017

Last Update Submit

February 15, 2017

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

Safety Assesment
Safety was assessed by: 1. All serious adverse events (SAEs) 2. All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib 3. Non-serious AEs assessed by the treating physician as related to afatinib.
From first administration of treatment until 28 days after last drug administration, up to 80 weeks.

Study Arms (1)

Afatinib

EXPERIMENTAL

patient to receive a tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability

Drug: Afatinib

Interventions

AfatinibDRUG

40, 30, or 20mg tablets taken once daily, dosage depending on tolerability

Afatinib

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
Epidermal Growth Factor Receptor (EGFR) mutation-positive results per the institution's testing methodology
Male or female patients age \>=18 years
Adequate organ function, defined as all of the following:
Absolute neutrophil count (ANC) \>1500/mm3
Platelet count\>75,000/mm3
Serum creatinine\<1.5 times of the upper limit of (institutional) normal and/or creatinine clearance (measured or calculated)\>45ml/min
Total bilirubin \<1.5 times upper limit of (institutional) normal
Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) \< three times the upper limit of (institutional) normal (if related to liver metastases \< five times ULN)
Eastern Cooperative Oncology Group (ECOG) score between 0-2
Written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonization (ICH)- Good Clinical Practice (GCP) guidelines and local law
Recovery from any previous therapy related toxicity to \<=CTCAE Grade 1 at study entry (except for stable sensory neuropathy \<=CTCAE Grade 2 and alopecia)

You may not qualify if:

Prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
Hormonal anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
Radiotherapy within 28 days prior to drug administration, except as follows:
Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
Single dose palliative treatment for symptomatic metastases outside above allowance to be discussed with sponsor prior to enrolling
Major surgery within 4 weeks before starting trial treatment or scheduled for surgery during the projected course of the trial
Known hypersensitivity to afatinib or any of its excipients
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment
Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 2 weeks after treatment has ended
Childbearing potential who:
are nursing or
are pregnant or
are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patients ability to comply with the trial or interfere with the evaluation of safety for the trial drug
Previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured
+6 more criteria

Contact the study team to confirm eligibility.