Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

NCT02695290 | Terminated Phase 4 Results

• 1 other identifier: 1200.208
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

There is a medical need for improving treatment of poor performance status patients with EGFR driver mutations and documenting safety and tolerability of existing agents.

Conditions

Carcinoma, Non-Small-Cell Lung; ErbB Receptors

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Occurrence of Adverse Events (AEs) Leading to Dose Reduction of Afatinib

  Percentage of patients with occurrence of Adverse Events (AEs) leading to dose reduction of afatinib.

  Up to 98 days

Secondary Outcomes (2)

• Percentage of Patients With Occurrence of CTCAE Grade 3 or Higher Diarrhoea, Rash/Acne+, Stomatitis+ and Paronychia+ (+ Represents Grouped Term)

  Up to 98 days

• Time to First Dose Reduction of Afatinib Caused by Adverse Events (AEs)

  Up to 98 days

Study Arms (1)

Afatinib

EXPERIMENTAL

Drug: Afatinib

Interventions

Afatinib DRUG

Afatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically or cytologically confirmed NSCLC
• Stage IV Cancer (includes cytologically proven pleural effusion or pericardial effusion) or recurrent disease. The staging is based on American Joint Committee on Cancer (AJCC) Tumor Node Metastatic (TNM) classification of malignant tumors, 7th edition
• Evidence of common EGFR activating mutations (Del 19 and/or L858R)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 or 3
• Adequate organ function, defined as all of the following:
• Absolute neutrophil count (ANC) \> 1500 / mm3
• Platelet count \>75,000 / mm3.
• Baseline creatinine of \< or = 1.5 g/dl or, if \> 1.5, an estimated creatinine clearance of \> 45 ml/min
• Total Bilirubin \< 1.5 times upper limit of institutional normal (ULN)
• Aspartate amino transferase (AST) or alanine amino transferase (ALT) \< three times ULN (if related to liver metastases \< five times ULN)
• Recovery from any previous therapy related toxicity to\< or = Grade 1 at study entry (except for stable sensory neuropathy \< or =Grade 2 and alopecia)
• Life expectancy of at least three months
• Written informed consent that is consistent with International Council on Harmonization- Good Clinical Practice (ICH-GCP) guidelines
• Age 18 or older

You may not qualify if:

• Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
• Prior systemic therapy for metastatic or recurrent NSCLC including prior treatment with EGFR targeting small molecules or antibodies. Note: radiotherapy alone and adjuvant/neoadjuvant treatment is not counted as a line of therapy.
• 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:
• i.) Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to study treatment, or ii.) Single dose palliative treatment (e.g Stereotactic Radio Surgery(SRS) or Stereotactic Body Radiation Therapy) (SBRT) 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
• Women of child-bearing potential (WOCBP) and men who are able to father a child, or use adequate contraception prior to study entry, for the duration of study participation and for at least 28 days after treatment has ended.
• Presence of an active infection or with a fever \> 38.5 C within 3 days of the first scheduled day of dosing
• Known hypersensitivity to afatinib or the excipients of afatinib
• Known pre-existing interstitial lung disease
• Presence of brain or subdural metastases, unless local therapy has been completed and use of corticosteroids has been discontinued or the dose has been stable for at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment (Pts post SRS can be enrolled earlier as long as their symptoms are stable or improved and they are off steroids)
• 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 2 years and is considered to be cured
• History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of 3 or 4 unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to treatment with afatinib.
• Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhoea, malabsorption)
• Known or suspected active hepatitis B (Hep B) infection (defined as presence of HepB (surface Antigen) sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1200.208.10032 Boehringer Ingelheim Investigational Site

Fountain Valley, California, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This study was stopped prematurely when only 1 patient had received afatinib treatment so it was not possible to draw any conclusion.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 1, 2016
• Study Start: March 17, 2016
• Primary Completion: August 26, 2016
• Study Completion: August 26, 2016
• Last Updated: September 18, 2017
• Results First Posted: September 18, 2017

Record last verified: 2017-09

Locations

US (1)